Start:
August 2014
End:
February 2016
Enrollment:
34
What Is This Study About?
This study is designed to obtain basic information about three PET imaging tracers developed to detect tau pathology in the brain. Abnormal tau is part of neurofibrillary tangles found in the brain of people with Alzheimer's. Healthy participants (controls) 25-40 or 50-80 years old and participants with Alzheimer's disease 50-80 years old may participate.
Do I Qualify To Participate in This Study?
Must have:
All Participants
- Agreement to use highly effective contraception measures
- If taking a medication, should be on stable dose for at least 4 weeks prior to start of study
- Body mass index (BMI) of 18-32
- Weight of 300 pounds or less
Healthy Controls
- Age 25-40 years or 50-80 years
- Normal cognitive function, including a normal Mini-Mental State Examination (MMSE) score
- Healthy control participants who receive the tracer [11C]RO6924963 must be less than 6'5" tall
Participants with Alzheimer's Disease
- Diagnosis of probable Alzheimer's disease, according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria
- Age 50-80 years
- Capacity for informed consent
- MMSE score between 16 and 26, inclusive
Must NOT have:
- History or presence of a neurological diagnosis other than Alzheimer's that may influence the outcome or analysis of the brain scan results; may include but is not limited to stroke, traumatic brain injury, space occupying lesions, non-Alzheimer's tauopathies, and Parkinson's disease
- Medical history that includes known autosomal dominant Alzheimer's mutations in amyloid precursor protein (APP) or presenilin (PS1, PS2) or mutations in genes that cause other types of autosomal dominant familial dementia
- History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system disease
- Other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study
- Clinically relevant pathological findings in physical examination, electrocardiogram, or laboratory values at the screening assessment that could interfere with the objectives of the study
- Known history of clinically significant infectious disease such as AIDS; indication of acute/chronic hepatitis B, hepatitis C, or HIV infection
- Pregnancy or lactation
- Unsuitable veins for repeated venipuncture
- History of drug allergy or hypersensitivity
- Alcohol consumption that averages more than three drinks daily
- Regular smoker (more than 10 cigarettes, three pipefuls, or three cigars per day)
- Coffee or tea consumption of more than 10 cups per day or methylxanthine-containing drinks of more than 1.5 L/day
- Has received an investigational medication within the last 3 months or 5 times the elimination half-life, whichever is longer, prior to enrollment
- Presence of any medical device or circumstance (such as claustrophobia) that would contraindicate a magnetic resonance imaging scan
- For participants who receive the tracers [11C]RO6924963 or [11C]RO6924963, any contraindications to arterial cannulation
- Participants with probable Alzheimer's disease: Treatment targeting amyloid-beta or tau within the last 24 months
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Collaborator Sponsor
Source:
ClinicalTrials.gov ID:
NCT02187627