Trial-Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD)

• Global Clinical Dementia Rating score of 0 or 0.5 and no diagnosis of dementia
• Study partner who is willing to participate as a source of information and has at least weekly contact (in-person, via telephone, or electronic communication) with the participant
• Good general health
• Adequate visual and auditory ability to allow neuropsychological testing
• Fluent in English or Spanish
• Females who are not surgically sterile or postmenopausal for 2 years must receive a negative pregnancy test prior to amyloid PET scan
• Completed six grades of education or has a good work history
• Evidence of elevated or intermediate levels of brain amyloid, as assessed by amyloid PET or cerebrospinal fluid data; prior amyloid testing results may be used with approval from the Coordinating Center

• Treatment with another anti-amyloid investigational drug or other intervention within past 12 months
• Enrolled in another interventional clinical trial within the last 12 weeks
• Any significant neurological disease such as Alzheimer's disease dementia, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
• Major depression, bipolar disorder, agitation or behavioral problems within the past 3 months that could lead to difficulty complying with the study; history of schizophrenia
• History of alcohol or substance abuse or dependence within the past 2 years
• Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease
• History within the last 3 years of a primary or recurrent malignant disease, with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
• Clinically significant abnormalities in vitamin B12 or thyroid function tests
• Clinically significant abnormalities in laboratory tests or electrocardiogram
• For participants undergoing cerebrospinal fluid collection, current blood clotting or bleeding disorder

TRC-PAD is an observational study designed to create a group of cognitively healthy volunteers willing to participate in clinical trials aimed at discovering treatments that will reduce the risk of developing Alzheimer's dementia. TRC-PAD will help researchers enroll participants into these trials quickly. Participants must be identified as being at risk for  memory loss caused by Alzheimer's disease based on a number of factors, including family history, performance on memory tests, genetics tests, and biomarker tests.

To join the TRC-PAD study, individuals must first complete an APT Webstudy online questionnaire and memory tests. If selected, participants will make an in-person visit to a study site, where they will complete several assessments to see if they qualify to join the cohort. These assessments include a positron emission tomography (PET) brain scan, cerebrospinal fluid collection, tests of memory and thinking, questionnaires about daily functioning, mood and behavior, genetic testing, and routine blood and urine tests. Individuals who enroll in TRC-PAD will come back to the clinic every 6 months for brief follow-up visits, with questionnaires and testing, until they qualify for a clinical trial.

University of Southern California

• National Institute on Aging (NIA)
• Alzheimer's Therapeutic Research Institute
• Alzheimer's Clinical Trials Consortium
• Brigham and Women's Hospital
• Cleveland Clinic Lou Ruvo Center for Brain Health