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Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4)
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Gisella.Rodriguez-Larrain@UTSouthwestern.edu
Trung Nguyen
ALL
55 Years to 90 Years old
NCT05617014
STU-2023-0505
Inclusion Criteria for Newly Enrolled Participants, CN Cohort:
• Participant may or may not have a significant subjective memory concern as reported by participant, study partner, or clinician.
• Normal memory function documented by scoring above demographically-adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
• ≥9 for 16 or more years of education
• ≥ 5 for 8-15 years of education
• ≥ 3 for 0-7 years of education
• Note: cut-offs may be modified over time as the field evolves in this area
• Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• Clinical Dementia Rating = 0. Memory Box score must be 0.
• Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living.
• Stability of Permitted Medications for 4 weeks. In particular, participants may:
• Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 years)
• Estrogen replacement therapy is permissible
• Gingko biloba is permissible, but discouraged
• Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria for Newly Enrolled Participants, MCI Cohort
• Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
• Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
• ≤11 for 16 or more years of education
• ≤9 for 8-15 years of education
• ≤6 for 0-7 years of education.
• Note: cut-offs may be modified over time as the field evolves in this area.
• Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
• General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by the site physician at the time of the screening visit.
• Stability of Permitted Medications for 4 weeks. In particular, participants may:
• Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
• Estrogen replacement therapy is permissible
• Gingko biloba is permissible, but discouraged
• Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
• Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen Inclusion Criteria for Newly Enrolled Participants, DEM Cohort
• Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
• Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
• ≤11 for 16 or more years of education
• ≤9 for 8-15 years of education
• ≤6 for 0-7 years of education.
• Note: cut-offs may be modified over time as the field evolves in this area.
• Mini-Mental State Exam score between 20 and 28 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• Clinical Dementia Rating = 0.5 or 1.0.
• Meets the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines for Dementia (2011)
• Stability of Permitted Medications for 4 weeks. In particular, participants may:
• Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
• Estrogen replacement therapy is permissible
• Gingko biloba is permissible, but discouraged
• Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
• Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen Inclusion Criteria for Newly Enrolled Participants, All Cohorts
• Geriatric Depression Scale score less than 10.
• Age between 55-90 years (inclusive).
• Study partner who has frequent contact with the participant (i.e., minimum average of 2 hours per week) and may be able to accompany the participant to clinic visits or provide information remotely (e.g. over the phone).
• Visual and auditory acuity adequate for neuropsychological testing.
• Good general health with no diseases expected to interfere with the study.
• Participant is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile).
• Willing and able to participate in a longitudinal imaging study.
• Must be literate and speak English or Spanish fluently.
• Agrees to collection of blood for GWAS, APOE testing, DNA and RNA testing
• Agrees to collection of blood for biomarker testing.
• The Administrative Core, described in section 9.1.1, will collaborate with leadership from all Cores to review the blood biomarker data from the remote blood cohort and select participants to join the in-clinic cohort. See ADNI4: Remote protocol.
• Agrees to participate in the ADNI study which includes cognitive evaluation, MRI and PET scans.
• Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood. Inclusion Criteria for Rollover Participants, All Cohorts The following additional inclusion criteria apply to all diagnostic categories for rollover participants only:
• Must have been enrolled and followed in one of the following previous ADNI studies: ADNIGO, ADNI2, ADNI3 for at least one year.
• Willing and able to continue to participant in an ongoing longitudinal study. A reduced battery of tests is allowable.
• Study partner may be available who has frequent contact with the participant (i.e., minimum average of 2 hours per week), and may be able to accompany the participant to clinic visits or provide information remotely (e.g. over the phone). Exclusion Criteria for Newly Enrolled Participants, CN Cohort:
• Any significant neurologic disease, such as Parkinson's disease, vascular cognitive impairment/dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities Exclusion Criteria for Newly Enrolled Participants, MCI and DEM Cohorts:
• Any significant neurologic disease other than suspected Alzheimer's disease, such as Parkinson's disease (Parkinsonian symptoms complicating MCI/AD are acceptable), vascular cognitive impairment dementia (multiple lacunes less than or equal to 1.5 cm and/or extensive white matter changes are acceptable), Huntington's disease, normal pressure hydrocephalus, brain tumor (clinically insignificant meningioma acceptable), progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. Exclusion Criteria for Newly Enrolled Participants, All Cohorts: Additional exclusion criteria apply to all diagnostic categories for newly enrolled participants:
• Screening/Baseline MRI brain scan with evidence of infection, or other clinically significant focal lesions. Participants with cortical strokes, not large enough to distort anatomy, multiple lacunar infarctions or extensive white matter disease are allowed.
• Screening/Baseline MRI brain scan with evidence of large structural abnormalities that would corrupt image analytical pipelines - e.g. large hemispheric infarcts, large areas of encephalomalacia, large arachnoid cysts
• Unable to complete MRIs for any reason (e.g. pacemaker or other implanted metal devices, severe claustrophobia, anxiety which prevents MRI scans, too large to fit, etc.).
• Current major depression, bipolar disorder as described in DMS-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
• Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
• History of schizophrenia (DSM-5 criteria).
• History of alcohol or substance disorder within the past 2 years (DSM-5 criteria).
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
• Clinically significant abnormalities in B12, or thyroid function tests that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
• Residence in skilled nursing facility
• Current use of specific psychoactive medications (e.g. certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.), at the discretion of the clinician.
• Current use of any other exclusionary medications.
• Investigational agents are prohibited for five half-lives or one month, whichever time period is longer, prior to entry and for the duration of the trial.
• Participation in clinical studies involving neuropsychological measures being collected more than once time per year.
• Female that is pregnant, lactating, or of childbearing potential.
• Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.
• Participant may or may not have a significant subjective memory concern as reported by participant, study partner, or clinician.
• Normal memory function documented by scoring above demographically-adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
• ≥9 for 16 or more years of education
• ≥ 5 for 8-15 years of education
• ≥ 3 for 0-7 years of education
• Note: cut-offs may be modified over time as the field evolves in this area
• Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• Clinical Dementia Rating = 0. Memory Box score must be 0.
• Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living.
• Stability of Permitted Medications for 4 weeks. In particular, participants may:
• Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 years)
• Estrogen replacement therapy is permissible
• Gingko biloba is permissible, but discouraged
• Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria for Newly Enrolled Participants, MCI Cohort
• Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
• Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
• ≤11 for 16 or more years of education
• ≤9 for 8-15 years of education
• ≤6 for 0-7 years of education.
• Note: cut-offs may be modified over time as the field evolves in this area.
• Mini-Mental State Exam score between 24 and 30 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5
• General cognition and functional performance sufficiently preserved such that a diagnosis of dementia cannot be made by the site physician at the time of the screening visit.
• Stability of Permitted Medications for 4 weeks. In particular, participants may:
• Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
• Estrogen replacement therapy is permissible
• Gingko biloba is permissible, but discouraged
• Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
• Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen Inclusion Criteria for Newly Enrolled Participants, DEM Cohort
• Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
• Abnormal memory function documented by scoring within the demographically- adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale - Revised (the maximum score is 25):
• ≤11 for 16 or more years of education
• ≤9 for 8-15 years of education
• ≤6 for 0-7 years of education.
• Note: cut-offs may be modified over time as the field evolves in this area.
• Mini-Mental State Exam score between 20 and 28 (inclusive) (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director and/or Clinical Core)
• Clinical Dementia Rating = 0.5 or 1.0.
• Meets the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines for Dementia (2011)
• Stability of Permitted Medications for 4 weeks. In particular, participants may:
• Take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past 1 year)
• Estrogen replacement therapy is permissible
• Gingko biloba is permissible, but discouraged
• Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening
• Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to screen
• Aducanumab and any other approved treatments for the neurobiology of AD if stable for 24 weeks prior to screen Inclusion Criteria for Newly Enrolled Participants, All Cohorts
• Geriatric Depression Scale score less than 10.
• Age between 55-90 years (inclusive).
• Study partner who has frequent contact with the participant (i.e., minimum average of 2 hours per week) and may be able to accompany the participant to clinic visits or provide information remotely (e.g. over the phone).
• Visual and auditory acuity adequate for neuropsychological testing.
• Good general health with no diseases expected to interfere with the study.
• Participant is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile).
• Willing and able to participate in a longitudinal imaging study.
• Must be literate and speak English or Spanish fluently.
• Agrees to collection of blood for GWAS, APOE testing, DNA and RNA testing
• Agrees to collection of blood for biomarker testing.
• The Administrative Core, described in section 9.1.1, will collaborate with leadership from all Cores to review the blood biomarker data from the remote blood cohort and select participants to join the in-clinic cohort. See ADNI4: Remote protocol.
• Agrees to participate in the ADNI study which includes cognitive evaluation, MRI and PET scans.
• Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood. Inclusion Criteria for Rollover Participants, All Cohorts The following additional inclusion criteria apply to all diagnostic categories for rollover participants only:
• Must have been enrolled and followed in one of the following previous ADNI studies: ADNIGO, ADNI2, ADNI3 for at least one year.
• Willing and able to continue to participant in an ongoing longitudinal study. A reduced battery of tests is allowable.
• Study partner may be available who has frequent contact with the participant (i.e., minimum average of 2 hours per week), and may be able to accompany the participant to clinic visits or provide information remotely (e.g. over the phone). Exclusion Criteria for Newly Enrolled Participants, CN Cohort:
• Any significant neurologic disease, such as Parkinson's disease, vascular cognitive impairment/dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities Exclusion Criteria for Newly Enrolled Participants, MCI and DEM Cohorts:
• Any significant neurologic disease other than suspected Alzheimer's disease, such as Parkinson's disease (Parkinsonian symptoms complicating MCI/AD are acceptable), vascular cognitive impairment dementia (multiple lacunes less than or equal to 1.5 cm and/or extensive white matter changes are acceptable), Huntington's disease, normal pressure hydrocephalus, brain tumor (clinically insignificant meningioma acceptable), progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. Exclusion Criteria for Newly Enrolled Participants, All Cohorts: Additional exclusion criteria apply to all diagnostic categories for newly enrolled participants:
• Screening/Baseline MRI brain scan with evidence of infection, or other clinically significant focal lesions. Participants with cortical strokes, not large enough to distort anatomy, multiple lacunar infarctions or extensive white matter disease are allowed.
• Screening/Baseline MRI brain scan with evidence of large structural abnormalities that would corrupt image analytical pipelines - e.g. large hemispheric infarcts, large areas of encephalomalacia, large arachnoid cysts
• Unable to complete MRIs for any reason (e.g. pacemaker or other implanted metal devices, severe claustrophobia, anxiety which prevents MRI scans, too large to fit, etc.).
• Current major depression, bipolar disorder as described in DMS-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
• Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder.
• History of schizophrenia (DSM-5 criteria).
• History of alcohol or substance disorder within the past 2 years (DSM-5 criteria).
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
• Clinically significant abnormalities in B12, or thyroid function tests that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant.
• Residence in skilled nursing facility
• Current use of specific psychoactive medications (e.g. certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.), at the discretion of the clinician.
• Current use of any other exclusionary medications.
• Investigational agents are prohibited for five half-lives or one month, whichever time period is longer, prior to entry and for the duration of the trial.
• Participation in clinical studies involving neuropsychological measures being collected more than once time per year.
• Female that is pregnant, lactating, or of childbearing potential.
• Flexibility can be made to all criteria for those with at least 8 years in a low socio-economic status (SES) neighborhood.
RADIATION: Neuraceq, RADIATION: Amyvid, RADIATION: Tauvid, RADIATION: MK-6240, RADIATION: NAV4694, RADIATION: PI-2620
Mild Cognitive Impairment, Alzheimer Disease, Dementia, Brain and Nervous System
amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, pre-dementia, dementia, Alzheimer's disease, tau, observational
UT Southwestern
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Matthew.Jones@UTSouthwestern.edu
Brendan Kelley
ALL
50 Years to 85 Years old
PHASE2
NCT05531656
STU-2024-0467
Inclusion Criteria:
• Ages 50-85 years.
• Diagnosis of either MCI due to AD or mild AD dementia.
• MMSE 20-30 (inclusive).
• Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
• Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.
Exclusion Criteria:
• Screening MRI of the brain indicative of significant abnormality.
• Clinically significant abnormalities in screening laboratory tests.
• Clinical or laboratory findings consistent with:
• Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
• Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
• Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
• A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen \[HbsAg\] or anti-hepatitis C \[HCV\] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
• A current DSM-V diagnosis of active major depression or GDS \> 6, schizophrenia, or bipolar disorder.
DRUG: CT1812, DRUG: Placebo
Early Alzheimer's Disease, Brain and Nervous System
Alzheimer's Disease
UT Southwestern
Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study) (IPAT)
The purpose of this study is to determine if intensive lowering of systolic blood pressure (SBP), using FDA approved medications (antihypertensive), reduces Alzheimer's Disease pathology (i.e., excessive brain amyloid and tau protein deposition) in older adults at high risk for memory decline or dementia.
Call 214-648-5005
studyfinder@utsouthwestern.edu, TristynHall@texashealth.org
Rong Zhang
ALL
60 Years to 85 Years old
PHASE2
NCT05331144
STU-2021-1210
Inclusion Criteria:
* Age 60-85, all races/ethnicities, and both sexes are eligible;
* Mini-Mental State Exam (MMSE) ≥ 26 to exclude gross dementia; based on clinical judgment, may be rescreened in ≥ 7 days;
* Individuals with SBP ≥ 130 and SBP ≤ 180 if on 0 or 1 antihypertensive medications; ≥130 and ≤170 on up to 2 medications; ≥130 and ≤160 on up to 3 medications; ≥130 and ≤150 on up to 4 medications. Those on antihypertensives are eligible. If an individual, not treated for hypertension (HTN), has a SBP ≥ 125 mmHg, consider rescreening after 24 hours;
* Willingness to be randomized into the treatment groups and ability to return to clinic for follow-up visits over 24 months;
* Fluency in English or Spanish or both, adequate visual and auditory acuity to allow neuropsychological testing;
* Participants must have a regular healthcare provider.
Exclusion Criteria:
* Clinically documented history of stroke, focal neurological signs or other major cerebrovascular diseases based on clinical judgment or MRI/CT scans such as evidence of infection, infarction, or other brain lesions;
* Diagnosis of AD or other type of dementia, or significant neurologic diseases such as Parkinson's disease, seizure disorder, multiple sclerosis, history of severe head trauma or normal pressure hydrocephalus;
* Evidence of severe major depression (GDS ≥ 12, may be rescreened after 12 weeks or longer if evidence of reactive depression or temporary mood disturbances) or clinically significant psychopathology, (e.g., psychosis and schizophrenia); if hospitalized in past year, can be rescreened in 6 months; or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures.
* Unstable heart disease based on clinical judgment (e.g., heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), or other severe medical conditions;
* History of atrial fibrillation and evidence on ECG with any of the following: active symptoms of persistent palpitation, dizziness, history of syncope, chest pain, dyspnea, orthopnea, shortness of breath at rest, or paroxysmal nocturnal dyspnea within the past 6 months; resting heart rate of \< 30 or \> 110 bpm; taking class I or III antiarrhythmic drugs including flecainide, propafenone, dronedarone, sotalol, dofetilide, and amiodarone; or clinical concerns for safely participating in lowering blood pressure.
* Systolic BP equal or greater than 180 mmHg and/or diastolic BP equal or greater than 110 mmHg, may be rescreened in 1 week.
* Orthostatic hypotension, defined as the third standing SBP \< 100mmHg, may be rescreened after 2 weeks;
* History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis or polymyalgia rheumatica;
* Significant history of alcoholism or drug abuse within the last five years;
* Uncontrolled diabetes mellitus, defined as hemoglobin A1C \> 7.5%, or requiring insulin treatment;
* Regularly smoking cigarettes within the past year;
* Pacemaker or other medical device of metal that precludes performing MRI;
* Women with a potential for pregnancy, lactation/childbearing (2 year post-menopausal or surgically sterile to be considered not childbearing potential);
* Participant enrolled in another investigational drug or device study, either currently or within the past 2 months;
* Severe obesity with BMI \> 40 ; clinical judgment should be applied in all cases to assess patient safety and anticipated compliance;
* Allergy to angiotensin receptor blockers (ARBs), i.e., drugs that have a suffix "-sartan"; allergy to amlodipine;
* Abnormal screening laboratory tests (e.g., liver ALT and AST \> 3 x ULN, GFR \< 30 or Hct \< 28%); may be rescreened after 2 weeks or longer;
* A medical condition likely to limit survival to less than 3 years;
* Participant has any condition(s) judged by the study investigator to be medically inappropriate, risky or likely to cause poor study compliance. For example:
• Plans to move outside the clinic catchment area in the next 2 years;
• Significant concerns about participation in the study from spouse, significant other, or family members;
• Lack of support from primary health care provider;
• Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the study clinic funds for screening or randomization visits;
• Residence in a nursing home; persons residing in an assisted living or retirement community are eligible if they meet the other criteria;
• Other medical, psychiatric, or behavioral factors that, in the judgment of the site PI or clinician, may interfere with study participation or the ability to follow the study Protocol.
• Couples or significant partners who live together cannot be enrolled or participate simultaneously in the study.
DRUG: Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine), OTHER: PCP
Cognitively Normal Older Adults, Hypertension, Subjective Cognitive Decline, Family History of Dementia, Brain and Nervous System
Dementia, Alzheimer's Disease, Cognitive Function, Blood Pressure, Amyloid, Tau
UT Southwestern
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Vida.Rhodes@UTSouthwestern.edu
Bhavya Shah
ALL
50 Years to 85 Years old
NA
NCT03671889
STU-2020-0931
Inclusion Criteria:
• Male or Female between 50-85 years of age
• Probable Alzheimer's Disease (AD)
• If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months
• Able to communicate sensations during the ExAblate MRgFUS procedure
• Ambulatory
Exclusion Criteria:
• MRI Findings
• Presence of unknown or MR unsafe devices anywhere in the body
• Significant cardiac disease or unstable hemodynamic status
• Relative contraindications to ultrasound contrast agent or PET amyloid tracer
• History of a bleeding disorder
• History of liver disease
• Known cerebral or systemic vasculopathy
• Significant depression and at potential risk of suicide
• Any contraindications to MRI scanning
• Any contraindication to lumbar puncture for collection of cerebral spinal fluid
• Untreated, uncontrolled sleep apnea
• History of seizure disorder or epilepsy
• Severely Impaired renal function
• Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
• Chronic pulmonary disorders
• Positive human immunodeficiency virus (HIV)
• Known apolipoprotein E allele (ApoE4) homozygosity
DEVICE: Blood Brain Barrier (BBB) Disruption
Alzheimer Disease, Brain and Nervous System
Alzheimer Disease, Alzheimer Syndrome, Magnetic Resonance guided Focal Ultrasound (MRgFUS), Blood-Brain Barrier, ExAblate
UT Southwestern
Late Onset Alzheimer's Disease (LOAD)
The goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Kimberly.Martinez@UTSouthwestern.edu
Ihab Hajjar
All
55 Years and over
NCT05010603
STU 082012-046
Inclusion Criteria:
• Established diagnosis of definite or probable AD or have a diagnosis of a related neurodegenerative disorder such as Frontotemporal Dementia (FTD) or Lewy Body Dementia (LBD) (will also recruit sporadic FTD and LBD) cases.
• a living sibling with probable or possible AD;
• a third living relative affected with AD (onset age 50 or older) or unaffected (60 or older);
• participants in the proband's generation with an identified companion serving as an informant;
• participants who have capacity to consent or participants lacking capacity to consent with a surrogate/proxy in place to provide consent.
Exclusion Criteria:
• failure to identify an appropriate informant;
• uncertainty of the clinical diagnosis of Alzheimer's disease or other related disorder;
• discovery of additional diagnosis that could account for the clinical manifestations;
• unwillingness to participate;
• failure to identify a living sibling with AD or other related disorder (except in the cases of sporadic FTD and sporadic LBD);
• participants lacking the capacity to consent who do not have a surrogate or proxy or next of kin to provide consent.
Genetic: Blood Draw, Other: Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test
Alzheimer Disease
Genetic testing, Genetic influence