Alzheimer DiseasePhase 3ANCHOR-ADNCT07142954
Epidemiology and Biomarker Study in Alzheimer's Disease
A Phase 3 study testing P-tau217 Test in people with Alzheimer Disease, run by Eli Lilly and Company at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- P-tau217 Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Aug 2025to Jul 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant must self-report unimpaired cognition.
- The participant must have adequate literacy, vision, and hearing for neuropsychological assessments at the time of screening.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
4 sites in 2 countries
Japan3 sites, 3 recruiting
- Recruiting
The University of Tokyo Hospital
Bunkyō City, 113-8654
81120023812
Yoshiki Niimi
- Recruiting
Souseikai Sumida Hospital
Tokyo, 130-0004
81120023812
Takuma Yonemura
- Recruiting
Higashi Shinjuku Clinic
Tokyo, 169-0072
81120023812
Hiroaki Kondo
United States1 site, 1 recruiting
- Recruiting
Care Access - Houston
Houston, Texas, 77054
877-791-0656
Ali Bajwa
About this study
Official title: A Longitudinal, Prospective Epidemiology Study in Alzheimer's Disease: Assessing Neurocognitive and Biomarker Changes and Health Outcomes in Individuals at Risk for Symptoms of Alzheimer's Disease (ANCHOR-AD)
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.
Read the detailed description
Study AACU is a non-drug interventional study. The intervention is annual plasma P-tau217 testing. Enrollment is anticipated to be approximately 3400 participants.
- Conditions
- Alzheimer Disease
- Being tested
- P-tau217 Test
- Keywords
- Preclinical Alzheimer's Disease, Primary Prevention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-tau217 TestOther
A plasma test measuring phosphorylated tau at Position 217 (P-tau217).
| Study group | Role | What they receive |
|---|---|---|
| Elevated Plasma P-tau217 Levels | Other | Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report. Receives: 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. Receives: Other: P-tau217 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Cognitive composite may consist of iDSSTm, ISLT, and 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.
Measured: Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI)
Measured: Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)
Measured: Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by CFI
Measured: Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by XpressO
Measured: Baseline up to 7 years
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
Measured: Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
Measured: Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
Measured: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
Measured: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
Measured: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
Measured: Baseline, Year 7
Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start25 Aug 2025
- Primary completionJul 2033 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142954
- Sponsor's protocol ID
- 27588
- Other IDs
- I5T-MC-AACU
- Acronym
- ANCHOR-AD
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Prospective Epidemiology Study in Alzheimer's Disease: Assessing Neurocognitive and Biomarker Changes and Health Outcomes in Individuals at Risk for Symptoms of Alzheimer's Disease (ANCHOR-AD)
- ClinicalTrials.gov ID
- NCT07142954
- Acronym / sponsor ID
- ANCHOR-AD / 27588
- Conditions
- Alzheimer Disease
- Keywords
- Preclinical Alzheimer's Disease, Primary Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study AACU is a non-drug interventional study. The intervention is annual plasma P-tau217 testing. Enrollment is anticipated to be approximately 3400 participants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elevated Plasma P-tau217 Levels | Other | Other: P-tau217 TestParticipants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report. |
| Not-Elevated P-tau217 Levels | Other | Other: P-tau217 TestParticipants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The participant must self-report unimpaired cognition.
- The participant must have adequate literacy, vision, and hearing for neuropsychological assessments at the time of screening.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-tau217 TestA plasma test measuring phosphorylated tau at Position 217 (P-tau217). | Other | Elevated Plasma P-tau217 Levels, Not-Elevated P-tau217 Levels |
Primary outcome
Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components
Time frame: Baseline up to 7 years
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.
12 secondary outcomes
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
Time frame: Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Cognitive Function Index (CFI)
Time frame: Baseline up to 7 years
Time to Cognitive Worsening within Cohorts as Measured by Montreal Cognitive Assessment XpressO version (XpressO)
Time frame: Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by CFI
Time frame: Baseline up to 7 years
Time to Cognitive Worsening Between Groups as Measured by XpressO
Time frame: Baseline up to 7 years
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
Time frame: Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
Time frame: Baseline, Year 7
Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
Time frame: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score
Time frame: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT
Time frame: Baseline, Year 7
Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm
Time frame: Baseline, Year 7
Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P-tau217 Test in people with Alzheimer Disease, run by Eli Lilly and Company at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components (time frame: Baseline up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.