Alzheimer's Disease Trial, Recruiting NCT04165109 Sponsor: University of Southern California Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, Recruiting

NCT04165109
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Down syndrome (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21, or partial trisomy 21), confirmed by genetic testing or medical records
  • You (or your legal representative on your behalf) are able to sign and date a consent form agreeing to take part
  • You are willing and available to follow all study procedures for the full length of the study, or until you are referred to another clinical trial
  • You are male or female, between 25 and 55 years old (inclusive)
  • You are generally in good health and have not been diagnosed with dementia
  • If you take any medications that affect the brain or nervous system, your dose has been stable for at least 4 weeks (new medications will be reviewed individually by the medical team)
  • You have adequate vision and hearing to complete thinking and memory tests
  • You have a mental age of 4 years or older, based on a specific intelligence test (KBIT-2) or medical records
  • You are able to complete the KBIT-2 intelligence test with a score of 40 or above
  • You speak English or Spanish fluently
  • You have a reliable person (such as a caregiver, sibling, or parent) who knows you well and can accurately provide information about your health history and symptoms

Who may not be able to join:

  • You have a serious or unstable medical condition that could affect your ability to take part, such as unstable psychiatric illness, unstable heart problems, chronic kidney failure, chronic liver disease, or severe lung disease
  • You are unable to have an MRI scan — for example, if you have a pacemaker that is not MRI-compatible, certain metal fragments near your eyes or spine, or a cochlear implant (note: dental fillings are not a problem)
  • You are unable to complete an MRI scan for any reason
  • You have had a cancer diagnosis in the last 5 years, with some exceptions such as certain minor skin cancers or early-stage cancers that have been successfully treated (confirm with trial site)
  • You have significantly abnormal vitamin B12 or thyroid levels in your blood tests that could interfere with the study (further follow-up tests may clarify whether this applies to you — confirm with trial site)
  • You have other significantly abnormal results from screening blood tests
  • If you are having spinal fluid (CSF) collected as part of the study: you have a blood clotting or bleeding disorder, significantly abnormal clotting results, or you take blood-thinning medication such as warfarin
  • You are currently taking part in another clinical trial testing an investigational product, or another long-term study with similar tests or procedures (with some exceptions — confirm with trial site)
  • The study investigators determine for any other reason that you are not suitable to participate (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Michael Rafii, MD, PhD, USC Alzheimer's Therapeutic Research Institute (ATRI)

Phone: 213-821-0569

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
7 June 2021
Est. completion
31 December 2027

Where this trial is recruiting

🇫🇷 France 🇮🇪 Ireland 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Enrollment of participants into the Trial-Ready Cohort in DS (TRC-DS).

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov