NCT07142954

Brief Summary

Study AACU determines rates of cognitive worsening in participants within elevated and not elevated plasma P-tau217 cohorts. Participation in AACU will last approximately 7 years.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,400

participants targeted

Target at P75+ for phase_3 alzheimer-disease

Timeline
87mo left

Started Aug 2025

Longer than P75 for phase_3 alzheimer-disease

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Aug 2025Jul 2033

First Submitted

Initial submission to the registry

August 20, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2033

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

7.9 years

First QC Date

August 20, 2025

Last Update Submit

February 9, 2026

Conditions

Alzheimer Disease

Keywords

Preclinical Alzheimer's DiseasePrimary Prevention

Outcome Measures

Primary Outcomes (1)

  • Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components

    Cognitive composite may consist of International Daily Symbol Substitution Test-Medicines (iDSSTm ), International Shopping List Test (ISLT), Continuous Paired Associate Learning Test (CPAL). Time to cognitive worsening is defined as a change in cognitive composite score or any of the individual composite components, from baseline at 2 consecutive visits.

    Baseline up to 7 years

Secondary Outcomes (12)

  • Time to Cognitive Worsening Between Groups (Participants Within Elevated and Not-Elevated Plasma P-Tau217) as Measured by Cognitive Composite or Any of the Individual Composite Components

    Baseline up to 7 years

  • Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI)

    Baseline up to 7 years

  • Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)

    Baseline up to 7 years

  • Time to Cognitive Worsening Between Groups as Measured by CFI

    Baseline up to 7 years

  • Time to Cognitive Worsening Between Groups as Measured by XpressO

    Baseline up to 7 years

  • +7 more secondary outcomes

Study Arms (2)

Elevated Plasma P-tau217 Levels

OTHER

Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

Other: P-tau217 Test

Not-Elevated P-tau217 Levels

OTHER

Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report.

Other: P-tau217 Test

Interventions

P-tau217 TestOTHER

A plasma test measuring phosphorylated tau at Position 217 (P-tau217).

Elevated Plasma P-tau217 LevelsNot-Elevated P-tau217 Levels

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participant must self-report unimpaired cognition.
  • The participant must have adequate literacy, vision, and hearing for neuropsychological assessments at the time of screening.

You may not qualify if:

  • Have seen a doctor about memory concerns.
  • Have a history or diagnosis of cognitive impairment, or significant other neurodegenerative disease that can affect cognition.
  • Are currently enrolled or have previously participated in any Alzheimer's Disease (AD)-related study involving an investigational drug intervention.
  • Are currently using or have previously used prescription medications for treatment of mild cognitive impairment (MCI) or dementia such as amyloid targeting therapy (that is, lecanemab, donanemab, aducanumab), cholinesterase inhibitors (for example, benzgalantamine, donepezil, galantamine, rivastigmine), and memantine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Care Access - Houston

Houston, Texas, 77054, United States

RECRUITING

The University of Tokyo Hospital

Bunkyō City, 113-8654, Japan

RECRUITING

Souseikai Sumida Hospital

Tokyo, 130-0004, Japan

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 27, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

July 1, 2033

Study Completion (Estimated)

July 1, 2033

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)US(1)