Alzheimer's Disease Trial, Recruiting NCT07516119 Sponsor: Prevention Research Consortium Corp. Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, Recruiting

NCT07516119
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:

  • People aged 55 years or older at the time of joining the trial.
  • People who have already had genetic testing confirming they carry at least one copy of the APOE ε4 gene variant (this can be from a doctor's test, a research study, or even a consumer DNA test such as 23andMe).
  • People who already have whole-genome sequencing (a detailed type of DNA test) on file and are willing to share those data files with the study team, OR people who have results from a different type of genetic array test covering Alzheimer's-related genes and are willing to share those (whether array data is suitable will be assessed case by case by the trial team). Note: the trial does not carry out these genetic tests — they must already be completed before joining.
  • People who are currently thinking and remembering normally, or who have only very mild cognitive changes, with no existing diagnosis of dementia (this is assessed using digital cognitive tests and/or a brief thinking test).
  • People who do not currently meet criteria for Alzheimer's-related mild cognitive impairment, based on blood or spinal fluid levels of a protein called pTau217 being below a certain threshold (confirm with trial site).
  • People who are able to understand and agree to take part in the study, and who can complete study activities such as clinic visits, thinking tests, and providing small biological samples.
  • People who are willing to wear or carry digital monitoring devices such as a smartwatch, an Oura Ring sleep tracker, or a smartphone app, and to take part in app-based thinking and speech tests.
  • People who are willing to sign forms allowing the study team to access their existing genetic data and relevant medical records for use in the study.

Who may not be able to join:

  • People who already have a diagnosis of dementia of any kind at the time of joining.
  • People with a significant neurological condition that the trial doctor believes could affect thinking test results or study outcomes — for example, Parkinson's disease, a stroke with lasting neurological effects, or epilepsy with frequent seizures.
  • People with a major psychiatric condition, such as uncontrolled severe depression or schizophrenia, that the trial doctor believes would significantly affect participation or the reliability of results.
  • People with a serious or unstable medical condition expected to limit life expectancy to less than approximately three years, such as unstable heart, liver, or kidney disease.
  • People who have taken an investigational drug or an Alzheimer's disease-modifying treatment within the six months before joining, if the trial team determines this could affect test results or biomarker readings.
  • People who are unable or unwilling to use the required digital monitoring tools and apps.
  • People who do not have prior genetic documentation confirming at least one APOE ε4 allele, who have no existing whole-genome sequencing or suitable genetic array data on file, or who are unwilling to share their existing genetic and medical record data with the study team.
  • People who already meet criteria for mild cognitive impairment related to Alzheimer's disease, based on elevated pTau217 levels in blood or spinal fluid.
  • Children, people who are pregnant, and prisoners are not included in this trial.

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 23 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: Foster Carr, MD, Prevention Research Consortium Corp.

Phone: 8772716078

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
Sponsor
Prevention Research Consortium Corp.
Registry
ClinicalTrials.gov
Start date
15 April 2026
Est. completion
15 April 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Conversion from Cognitively Normal (CN) pTau217 Negative to pTau217-Positive

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: 23 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