Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5T-MC-AACU | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Study AACU is a non-drug interventional study. The intervention is annual plasma P-tau217 testing. Enrollment is anticipated to be approximately 3400 participants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevated Plasma P-tau217 Levels | Other | Participants with known elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report. |
|
| Not-Elevated P-tau217 Levels | Other | Participants with known not-elevated plasma P-tau217 levels who are cognitively unimpaired at baseline per self-report. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P-tau217 Test | Other | A plasma test measuring phosphorylated tau at Position 217 (P-tau217). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Access - Houston | Recruiting | Houston | Texas | 77054 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| The University of Tokyo Hospital | Recruiting | Bunkyō City | 113-8654 | Japan |
|
| Souseikai Sumida Hospital | Recruiting | Tokyo | 130-0004 | Japan |
|
| Higashi Shinjuku Clinic | Recruiting | Tokyo | 169-0072 | Japan |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |