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La información sobre este estudio está en inglés.

Si necesita ayuda en español, comuníquese con el Centro de Educación y Referencias sobre la Enfermedad de Alzheimer y las Demencias Relacionadas (ADEAR, por sus siglas en inglés) por teléfono al 800-438-4380 o envíe un correo electrónico. También puede llamar o enviar un correo electrónico al contacto del estudio (en inglés) para obtener información adicional.

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

Start: June 4, 2019
End: April 30, 2023
Enrollment: 2000

What Is This Study About?

The Trial-Ready Cohort for the Prevention of Alzheimer's Dementia (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. To join the TRC-PAD study, individuals must first complete an Alzheimer Prevention Trials (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 six months for brief follow-up visits, with questionnaires and testing, until they qualify for a clinical trial.

Do I Qualify To Participate in This Study?

Minimum Age: 50 Years

Maximum Age: 85 Years

Must have:

  • 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 two 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

Must NOT have:

  • Treatment with another anti-amyloid drug or other experimental treatment within past 12 months; use of aducanumab or other FDA-approved anti-amyloid treatments allowed, if dosage stable for at least three 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 three months that could lead to difficulty complying with the study; history of schizophrenia
  • History of alcohol or substance abuse or dependence within the past two 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 three 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
 

Who Is the General Study Contact?

For more information visit the TRC-PAD website.

Study Contact
APT / TRC Recruitment Team

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?

Alabama
University of Alabama
Birmingham, AL 35294
Recruiting
Arizona
Banner Alzheimer's Institute
Phoenix, AZ 85006
Recruiting
Banner Sun Health Research Institute
Sun City, AZ 85351
Recruiting
California
Sun Valley Research Center, Inc
Imperial, CA 92251
Not yet recruiting
University of California, Irvine
Irvine, CA 92697
Recruiting
University of Southern California
Los Angeles, CA 90033
Recruiting
Connecticut
Yale University
New Haven, CT 06510
Recruiting
District of Columbia
Georgetown University
Washington, DC 200072145
Recruiting
Florida
Mayo Clinic Jacksonville
Jacksonville, FL 32224
Recruiting
Gonzalez MD & Aswad MD Health Services
Miami, FL 33125
Recruiting
Wien Center for Alzheimer's Disease
Miami Beach, FL 33140
Recruiting
Renstar Medical Research
Ocala, FL 34470
Recruiting
Synexus Clinical Research Orlando
Orlando, FL 32806
Recruiting
Progressive Medical Research
Port Orange, FL 32127
Recruiting
Brain Matters Research
Stuart, FL 34997
Recruiting
University of South Florida - Health Byrd Alzheimer Institute
Tampa, FL 33613
Recruiting
Synexus Clinical Research, The Villages
The Villages, FL 32162
Recruiting
Charter Research, LLC
Winter Park, FL 32792
Recruiting
Georgia
Columbus Memory Center
Columbus, GA 31909
Recruiting
Illinois
Northwestern University
Chicago, IL 60611
Recruiting
Rush University
Chicago, IL 60612
Recruiting
Indiana
Indiana University
Indianapolis, IN 46202
Recruiting
Kansas
University of Kansas
Fairway, KS 66205
Recruiting
Kentucky
University of Kentucky
Lexington, KY 40504
Recruiting
Maryland
Johns Hopkins University
Baltimore, MD 21224
Recruiting
Massachusetts
Brigham & Women's Hospital
Boston, MA 02115
Recruiting
Headlands Eastern MA, LLC
Plymouth, MA 02360
Recruiting
Michigan
University of Michigan
Ann Arbor, MI 48105
Recruiting
Minnesota
Mayo Clinic Rochester
Rochester, MN 55902
Recruiting
Missouri
Washington University, St. Louis
Saint Louis, MO 63130
Recruiting
Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, NV 89106
Recruiting
New York
University of Rochester Medical Center
Rochester, NY 14620
Recruiting
North Carolina
Wake Forest University Health Sciences
Winston-Salem, NC 27157
Recruiting
Ohio
Case Western Reserve University
Beachwood, OH 44195
Recruiting
Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland
Cleveland, OH 44195
Recruiting
Ohio State University
Columbus, OH 43210
Recruiting
Oregon
Oregon Health & Science University
Portland, OR 97239
Recruiting
Pennsylvania
Abington Neurological Associates
Abington, PA 19001
Recruiting
University of Pennsylvania
Philadelphia, PA 19104
Recruiting
Rhode Island
Rhode Island Hospital
Providence, RI 02903
Recruiting
Butler Hospital Memory and Aging Program
Providence, RI 02908
Recruiting
South Carolina
Ralph H. Johnson VA Medical Center
Charleston, SC 29401
Not yet recruiting
Texas
University of Texas Southwestern Medical Center
Dallas, TX 75390
Recruiting
University of North Texas Health Sciences Center
Fort Worth, TX 76107
Recruiting
Virginia
National Clinical Research, Inc.
Richmond, VA 23294
Recruiting
Washington
University of Washington / Seattle Institute for Biomedical and Clinical Research
Seattle, WA 98108
Recruiting
Wisconsin
University of Wisconsin-Madison
Madison, WI 53792
Recruiting

Who Sponsors This Study?

Lead: University of Southern California

Collaborator Sponsor

  • 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

Source: ClinicalTrials.gov ID: NCT04004767

 

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