Phase 3 Alzheimer's Disease Trial, Recruiting NCT05456503 Sponsor: University of Pennsylvania Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT05456503
Recruiting Phase 3

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:

  • People aged 18 or older who are already enrolled in a related study called UNICORN (IRB #842873).
  • People who fall into one of seven specific groups: (1) those with no known brain or cognitive conditions and no family history of early-onset brain disease in parents or siblings; (2) those diagnosed with a non-memory-focused form of Alzheimer's disease; (3) those diagnosed with a brain condition likely caused by a protein called tau (such as PSP, CBS, or certain speech and behaviour conditions); (4) those diagnosed with a brain condition likely caused by a protein called TDP-43 (such as ALS-FTD or a language condition called svPPA); (5) those enrolled in UNICORN with a gene change in the MAPT gene linked to tau-related brain disease, whether or not they have symptoms; (6) those enrolled in UNICORN with a gene change in the GRN gene or the C9orf72 gene linked to TDP-43-related brain disease, whether or not they have symptoms; or (7) those diagnosed with memory-focused mild cognitive impairment or Alzheimer's disease.
  • People who score within a certain range on a standard depression screening (done within the past 6 months), or who have been assessed by a trained clinician as not clinically depressed.
  • People in groups 2 through 7 who have a study partner able to take part as required by the trial, and a legal authorised representative if applicable (confirm with trial site).

Who may not be able to join:

  • People with medical or psychiatric conditions that, in the investigator's opinion, could affect their safety or ability to take part in the study.
  • People whose UNICORN study records show significant structural brain changes — such as a major stroke or growth on the brain seen on an MRI scan within the past 6 months — that could interfere with the brain scan used in this trial.
  • People who are unable to tolerate, or who have a medical reason preventing them from having, the imaging procedures used in this study.
  • People who are pregnant or breastfeeding at the time of the first brain scan (a urine pregnancy test will be carried out for women who could become pregnant, at screening and within 24 hours before any scheduled scan).
  • People with a significant history of past or ongoing alcohol or substance misuse (this may be assessed at the investigator's discretion).
  • People who are currently taking part in another clinical trial for a treatment aimed at changing the course of their brain disease at a biological level.

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 21 July 2026
Phase 3: approximately ~65% 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: Jeffrey S Phillips, University of Pennsylvania

Phone: 215-662-3361

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 3
Registry
ClinicalTrials.gov
Start date
19 September 2022
Est. completion
1 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Whole brain SUVR; Regional brain SUVR

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: 21 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