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Trial-Ready Cohort-Down Syndrome (TRC-DS)

Alzheimer's Clinical Trial Consortium for Down Syndrome (ACTC-DS) Trial-Ready Cohort - Down Syndrome (TRC-DS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows healthy adults with Down syndrome, ages 25–55, who do not have dementia. It uses thinking tests, health checks, scans, and lab tests to learn how signs of Alzheimer's disease relate to changes in thinking over time. The goal is to help plan future Alzheimer's clinical trials for people with Down syndrome.

The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 550 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Down syndrome confirmed by genetic testing or medical records, and be age 25–55.
  • Be in good general health and have no diagnosis of dementia.
  • Sign a consent form. If you cannot give consent, a legally authorized person must sign for you, and you must sign a form showing you agree.
  • Be willing and available to complete study tasks for the study's length or until referred to a clinical trial.
  • If taking allowed medicines that affect the brain or nerves, have a steady dose for at least 4 weeks or longer. The study team will review any new medicines.
  • Be able to see and hear well enough for thinking tests, and speak English or Spanish fluently.
  • Have thinking and language skills at least at a 4-year-old level, based on testing or records. Be able to complete the KBIT-2 thinking test with an IQ score of at least 40.
  • Have a reliable study partner, such as a caregiver or family member, who can share accurate health history and symptom information.

Who can't join

  • Have a serious illness or a health condition that is not stable and could affect participation.
  • Cannot safely have or complete an MRI scan, which takes pictures inside the body. Some metal implants make MRI unsafe; dental fillings do not.
  • Have had cancer in the past 5 years, except for certain skin cancers and certain early cancers of the cervix or prostate described in the study rules.
  • Have important abnormal screening blood tests, including low vitamin B12 or abnormal thyroid tests. Follow-up tests may show that some results do not rule you out.
  • If giving a sample of fluid around the brain and spine: have a bleeding or blood-clotting disorder, abnormal clotting tests, or take blood-thinning medicine such as warfarin.
  • Are in a trial of an experimental product or another ongoing study with overlapping tests or procedures. Joining ABC-DS at the same time is allowed; other exceptions need the project director's approval.
  • The study doctor decides you are not eligible for another reason.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Diagnosis of DS (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21 or partial trisomy 21) (as confirmed by genetic testing or medical record review) 2. Provision of signed and dated informed consent form; this includes adults with DS who can provide consent, or for whom an LAR provides consent on behalf of the individual to participate. Adults with DS who cannot consent must sign and date an assent accompanied with a signed and dated consent by legally authorized representative (LAR). 3. Stated availability and willingness to comply with all study procedures and availability for the duration of the study or until referred to a clinical trial 4. Male or female, aged 25-55 inclusive 5. In good general health as evidenced by medical history with no diagnosis of dementia 6. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, medical monitoring team will review on case by case basis to recommend timing of baseline cognitive testing 7. Adequate visual and auditory acuity to allow neuropsychological testing 8. Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, Second Edition, KBIT-2, verbal age equivalent, or based upon medical records) 9. Ability to complete KBIT-2 with IQ equal to or greater than 40 10. Must speak English or Spanish fluently 11. Must have a reliable Study Partner (may be caregiver, sibling, parent) who is capable of providing correct information about the participant's clinical symptoms and history Exclusion Criteria: 1. Any significant disease or unstable medical condition that could affect participation (i.e., unstable psychiatric disease, unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease) 2. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a non-compatible pacemaker, presence of MRI-incompatible metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI) 3. Participants unable to complete MRI procedure 4. History, within the last 5 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 5. Clinically significant abnormalities in B12 or 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. A high TSH is exclusionary unless follow up T3/T4 levels indicate that it is not physiologically significant. 6. Clinically significant abnormalities in screening laboratories 7. 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 therapy (e.g. warfarin) 8. Concurrent participation in a clinical trial for an investigational product or concurrent participation in longitudinal study with overlapping outcome measures/procedures is prohibited with the exception of ABC-DS co-enrollment or as approved by project director 9. Participants whom the investigator deems to be otherwise ineligible. The Investigators should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC-DS would be appropriate

Study sites (18)

AZ

  • Barrow Neurological Institute · Phoenix, AZ 85013Anna Burke, MD · Principal investigatorMore trials in Phoenix

CA

  • University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only · Orange, CA 92868Ira Lott · Principal investigatorMore trials in Orange

CO

  • Linda Crnic Institute for Down Syndrome, University of Colorado · Aurora, CO 80045Joaquin Espinosa, PhD · Principal investigatorMore trials in Aurora

IL

  • Advocate Medical Group Adult Down Syndrome Center · Park Ridge, IL 60068Brian Chicoine, MD · Principal investigatorMore trials in Park Ridge

IN

KS

  • University of Kansas Medical Center · Kansas City, KS 66160Lauren T Ptomey, PhD, RD, LD · Principal investigatorMore trials in Kansas City

KY

  • University of Kentucky, Co-Enrolling through ABC-DS Only · Lexington, KY 40504Frederick Schmitt, PhD · Principal investigatorMore trials in Lexington

MA

  • Massachusetts General Hospital, Co-Enrolling through ABC-DS Only · Boston, MA 02114Herminia Herminia Diana Rosas · Principal investigatorMore trials in Boston

MO

  • Washington University, St. Louis · St Louis, MO 63108Beau Ances, MD, PhD · Principal investigatorMore trials in St Louis

NV

  • Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas · Las Vegas, NV 89106Charles Bernick, MD · Principal investigatorMore trials in Las Vegas

NY

  • New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only · Staten Island, NY 10314Sharon Krinsky-McHale, PhD · Principal investigatorMore trials in Staten Island

OH

OR

  • Oregon Health & Science University · Portland, OR 97239Aimee Pierce, MD · Principal investigatorMore trials in Portland

PA

  • University of Pittsburgh, Co-Enrolling through ABC-DS Only · Pittsburgh, PA 15213Benjamin Handen · Principal investigatorMore trials in Pittsburgh

TN

  • Vanderbilt University Medical Center Center for Cognitive Medicine · Nashville, TN 37212Paul Newhouse, MD · Principal investigatorMore trials in Nashville

TX

  • University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases · San Antonio, TX 78229Sarah Savoia, PAC-C · Principal investigatorMore trials in San Antonio

WI

  • University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only · Madison, WI 53705Bradley Christian · Principal investigatorMore trials in Madison