Alzheimer Disease Clinical Trial
— TRC-PADOfficial title:
Trial Ready Cohort for the Prevention of Alzheimer's Dementia (TRC-PAD)
Verified date | March 2024 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of the TRC-PAD study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).
Status | Active, not recruiting |
Enrollment | 2000 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated availability and willingness to comply with all study procedures until referred to a clinical trial 3. Age 50-85 (inclusive) 4. Global Clinical Dementia Rating (CDR) score of 0 or 0.5 and no diagnosis of dementia 5. Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the participant's daily function. 6. In good general health as evidenced by medical history 7. Adequate visual and auditory acuity to allow neuropsychological testing 8. Fluent in English or Spanish 9. For females who are not surgically sterile or post-menopausal by two years, receiving a Positron Emission Tomography (PET) scan for amyloid biomarker confirmation: negative pregnancy test prior to amyloid PET scan 10. Completed six grades of education or has a good work history 11. Evidence of elevated or intermediate (subthreshold) levels brain amyloid as assessed by central review of amyloid PET or cerebrospinal fluid (CSF) data. Prior amyloid testing results may be used with approval from the Coordinating Center. Exclusion Criteria: 1. Treatment with an another anti-amyloid investigational anti-amyloid drug or other experimental intervention within 12 months. Use of aducanumab or other approved anti-amyloid treatments allowed if stable for at least 3 months. 2. Enrolled in another interventional clinical trial within the last 12 weeks 3. Any significant neurologic 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 followed by persistent neurologic deficits or known structural brain abnormalities. 4. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol 5. History of schizophrenia (DSM V criteria) 6. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria) 7. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study. 8. 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 9. Clinically significant abnormalities in B12 or thyroid function tests (TFTs) 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. 10. Clinically significant abnormalities in screening laboratories or ECG. 11. For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g. warfarin) 12. Participants whom the Site PI deems to be otherwise ineligible. |
Country | Name | City | State |
---|---|---|---|
United States | Abington Neurological Associates | Abington | Pennsylvania |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Case Western Reserve University | Beachwood | Ohio |
United States | University of Alabama | Birmingham | Alabama |
United States | Brigham & Women's Hospital | Boston | Massachusetts |
United States | Ralph H. Johnson VA Medical Center | Charleston | South Carolina |
United States | Roper St. Francis Hospital | Charleston | South Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University | Chicago | Illinois |
United States | Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Brain Matters Research | Delray Beach | Florida |
United States | University of Kansas | Fairway | Kansas |
United States | University of North Texas Health Sciences Center | Fort Worth | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | University of California, Irvine | Irvine | California |
United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
United States | Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada |
United States | University of Kentucky | Lexington | Kentucky |
United States | University of Southern California | Los Angeles | California |
United States | University of Wisconsin-Madison | Madison | Wisconsin |
United States | Gonzalez MD & Aswad MD Health Services | Miami | Florida |
United States | Wien Center for Alzheimer's Disease | Miami Beach | Florida |
United States | Yale University | New Haven | Connecticut |
United States | Renstar Medical Research | Ocala | Florida |
United States | Synexus Clinical Research Orlando | Orlando | Florida |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Banner Alzheimer's Institute | Phoenix | Arizona |
United States | Headlands Eastern MA LLC | Plymouth | Massachusetts |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Butler Hospital Memory and Aging Program | Providence | Rhode Island |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | National Clinical Research, Inc. | Richmond | Virginia |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Washington University, St. Louis | Saint Louis | Missouri |
United States | University of Washington / Seattle Institute for Biomedical and Clinical Research | Seattle | Washington |
United States | Banner Sun Health Research Institute | Sun City | Arizona |
United States | University of South Florida - Health Byrd Alzheimer Institute | Tampa | Florida |
United States | Synexus Clinical Research, The Villages | The Villages | Florida |
United States | Georgetown University | Washington | District of Columbia |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | Charter Research, LLC | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Alzheimer's Clinical Trials Consortium, Alzheimer's Therapeutic Research Institute, Brigham and Women's Hospital, Cleveland Clinic Lou Ruvo Center for Brain Health, National Institute on Aging (NIA) |
United States,
Amariglio RE, Donohue MC, Marshall GA, Rentz DM, Salmon DP, Ferris SH, Karantzoulis S, Aisen PS, Sperling RA; Alzheimer's Disease Cooperative Study. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument. JAMA Neurol. 2015 Apr;72(4):446-54. doi: 10.1001/jamaneurol.2014.3375. Erratum In: JAMA Neurol. 2015 May;72(5):608. — View Citation
Mormino EC, Papp KV, Rentz DM, Donohue MC, Amariglio R, Quiroz YT, Chhatwal J, Marshall GA, Donovan N, Jackson J, Gatchel JR, Hanseeuw BJ, Schultz AP, Aisen PS, Johnson KA, Sperling RA. Early and late change on the preclinical Alzheimer's cognitive composite in clinically normal older individuals with elevated amyloid beta. Alzheimers Dement. 2017 Sep;13(9):1004-1012. doi: 10.1016/j.jalz.2017.01.018. Epub 2017 Feb 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Enrollment into preclinical and prodromal AD clinical trials | 5 years | ||
Secondary | Optimization of adaptive risk algorithm to predict risk of amyloid positivity | The TRC-PAD program aims to optimize an innovative, adaptive risk algorithm to efficiently identify the most appropriate trial participants. Once optimized, this algorithm will be able to select amyloid positive individuals (and eventually tau and other neurodegenerative biomarkers) with >75% accuracy, greatly reducing future costly biomarker screen fails. | 5 years |
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