Phase 2 Alzheimer's Disease Trial, Recruiting NCT05231798 Sponsor: Vanderbilt University Medical Center Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT05231798
Recruiting Phase 2

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 mosaic Down syndrome or partial trisomy 21.
  • You are willing to sign a consent form (or have a legal representative sign on your behalf) and agree to follow all study requirements for the full length of the study.
  • You are between 18 and 55 years old (inclusive).
  • You are in generally good health with no diagnosis of dementia.
  • Any medications that affect the brain have been at a stable dose for at least 4 weeks (if you recently started a new one, the study team will review your situation individually).
  • You have enough vision and hearing to complete thinking and memory tests.
  • If you are a female who has not had surgery to prevent pregnancy and have not been through menopause for at least two years, you must have a negative pregnancy test within 24 hours before a brain scan.
  • You have a mental age of 4 years or older, based on a specific intelligence test (the KBIT-2).
  • English is your first or native language.
  • You have a reliable study partner (such as a caregiver, sibling, or parent) who can share 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 thinking and memory tests, such as 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, metal fragments near your eyes or spine, or a cochlear implant (note: dental fillings are not a problem).
  • You are unable to complete the MRI and PET brain scanning procedures required by the study.
  • Your IQ score is below 40 on the KBIT-2 intelligence test.
  • You are currently pregnant or breastfeeding.
  • You have been diagnosed with cancer in the last 5 years, with some exceptions such as certain minor skin cancers that have been successfully treated (confirm with trial site).
  • You have significantly abnormal vitamin B12 or thyroid levels that could interfere with the study, unless follow-up tests show these are not a real concern (confirm with trial site).
  • You have other significantly abnormal results from your screening blood tests.
  • If spinal fluid collection applies to you: you have a blood clotting or bleeding disorder, or abnormal clotting test results, or you take blood-thinning medication such as warfarin.
  • The doctor leading the study at your location decides you are not suitable for another reason.
  • You have a clinical diagnosis of dementia.
  • You are currently taking part in another clinical trial for an experimental treatment, or another long-term study that uses similar tests or procedures.

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 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Alexander C Conley, Ph.D., Vanderbilt University Medical Center

Phone: 615-327-7117

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
Phase 2
Registry
ClinicalTrials.gov
Start date
19 August 2021
Est. completion
30 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

[18F]-FEOBV radiotracer standardized uptake value ratio correlation with the Basal Forebrain Cholinergic System Volume.

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: 26 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