Alzheimer Disease
Conditions
Keywords
Preclinical Alzheimer's Disease, Primary Prevention
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.
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.
Interventions
OTHERP-tau217 Test
A plasma test measuring phosphorylated tau at Position 217 (P-tau217).
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* The participant must self-report unimpaired cognition. * The participant must have adequate literacy, vision, and hearing for neuropsychological assessments at the time of screening.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cognitive Worsening Within Cohorts as Measured by Cognitive Composite or Any of the Individual Composite Components | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | — |
| Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score | Baseline, Year 7 | — |
| Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT | Baseline, Year 7 | — |
| Change from Baseline Within Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm | Baseline, Year 7 | — |
| Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by Cognitive Composite Score | Baseline, Year 7 | — |
| Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by ISLT | Baseline, Year 7 | — |
| Change from Baseline Between Not-Elevated and Elevated P-tau217 Groups as Measured by iDSSTm | Baseline, Year 7 | — |
| Weighted Proportion of Participants with Elevated Plasma P-tau217 Levels in US and Japan with Unimpaired Cognition at Baseline | Baseline | — |
Countries
Japan, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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
Outcome results
None listed