Clinical trial
Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Name
AAAR8986
Description
The study employs tau positron emission tomography (PET) imaging in a well-characterized multi-racial/ethnic cohort to examine the extent to which tau pathology is associated with cognition, differences in tau pathology across racial/ethnic groups, and the relationship between MRI markers of small-vessel cerebrovascular disease and tau pathology. The study also investigates amyloid-dependent tau spreading.
Trial arms
Trial start
2019-03-22
Estimated PCD
2023-07-14
Trial end
2023-07-14
Status
Completed
Phase
Early phase I
Treatment
18F-MK-6240
Administration of 5 mCi of 18F-MK-6240 for tau PET.
Arms:
Offspring Cohort
Other names:
[18F]MK-6240
18F-Florbetaben
Administration of 8.1 mCi as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL of 18F-Florbetaben for Aβ PET imaging.
Arms:
Offspring Cohort
Other names:
[18F]Florbetaben
Size
145
Primary endpoint
Regional SUVR value for 18F-MK-6240
Up to 5 years
Amyloid Positivity (Aβ+) for 18F-Florbetaben
Up to 5 years
Eligibility criteria
Inclusion Criteria:
* Aged 35 - 85 years
* Have either mild cognitive impairment or mild clinical Alzheimer's disease; or have no problem with memory or thinking.
* Able to participate in all scheduled evaluations and to complete all required tests and procedures
* Considered likely to comply with the study protocol and to have a high probability of completing the study
Exclusion Criteria:
* Past or present history of a certain brain disease other than mild cognitive impairment or mild clinical Alzheimer's disease.
* Certain significant medical conditions. Examples are uncontrolled epilepsy or multiple serious injuries.
* Unable to lie still for PET scans.
* Radiation exposure for research studies in the last year that would put you past allowable limits if included in this study.
* Participation in the last year in a clinical trial for a disease modifying drug for AD unless it can be determined that your received placebo and not active drug.
* Conditions that preclude entry into the scanner (e.g. claustrophobia, etc.).
* Inability to have a catheter in your vein for the injection of the radioligand (dye).
* Currently pregnant or breastfeeding.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 145, 'type': 'ACTUAL'}}
Updated at
2023-09-18
1 organization
2 products
1 indication
Organization
Adam BrickmanProduct
18F-MK-6240Indication
Alzheimer's diseaseProduct
18F-Florbetaben