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New study prepares adults with down syndrome for Alzheimer's trials

NCT ID NCT04165109

Knowledge-focused Sponsor: University of Southern California Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study enrolls adults with Down syndrome ages 25-55 into a ready-to-test group. Researchers will track memory, thinking, and brain changes over time to better understand how Alzheimer's disease develops in this population. The goal is to make future clinical trials faster and more effective by having a pre-screened group ready to join.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

120 non-demented adults with Down syndrome and up to 550 participants in total including co-enrollment the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS)

Ages

25 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia Down syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Dementia Down syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Medical Group Adult Down Syndrome Center

    NOT_YET_RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Barrow Neurological Institute

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Case Western Reserve University

    RECRUITING

    Beachwood, Ohio, 44122, United States

  • Cleveland Clinic, Lou Ruvo Center for Brain Health, Las Vegas

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Institut Jerome Lejeune

    RECRUITING

    Paris, France, 75018, France

  • Institute of Memory & Cognition, Tallaght University Hospital

    RECRUITING

    Dublin, Ireland, 24, Ireland

  • Linda Crnic Institute for Down Syndrome, University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Massachusetts General Hospital, Co-Enrolling through ABC-DS Only

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only

    RECRUITING

    Staten Island, New York, 10314, United States

  • Oregon Health & Science University

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Sant Pau Biomedical Research Institute (IIB Sant Pau)

    RECRUITING

    Barcelona, 08041, Spain

  • University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only

    RECRUITING

    Orange, California, 92868, United States

  • University of Cambridge, Co-Enrolling through ABC-DS Only

    RECRUITING

    Cambridge, CB2 1TN, United Kingdom

  • University of Cincinnati

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky, Co-Enrolling through ABC-DS Only

    RECRUITING

    Lexington, Kentucky, 40504, United States

  • University of Pittsburgh, Co-Enrolling through ABC-DS Only

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    RECRUITING

    Nashville, Tennessee, 37212, United States

  • Washington University, St. Louis

    RECRUITING

    St Louis, Missouri, 63108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.