A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03518073|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2018
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease (AD)||Drug: LY3303560 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||285 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Assessment of Safety, Tolerability, and Efficacy of LY3303560 in Early Symptomatic Alzheimer's Disease|
|Actual Study Start Date :||April 30, 2018|
|Estimated Primary Completion Date :||August 23, 2021|
|Estimated Study Completion Date :||October 22, 2021|
Experimental: LY3303560 Dose 1
LY3303560 administered intravenously (IV).
Experimental: LY3303560 Dose 2
LY3303560 administered IV.
Placebo Comparator: Placebo
Placebo administered IV.
- Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, 104 weeks ]Change from baseline on the iADRS.
- Change from Baseline on the Alzheimer's Disease Assessment Scale—Cognitive Subscale (ADAS-Cog13) Score [ Time Frame: Baseline, 104 weeks ]Change from baseline on the ADAS—Cog13 score.
- Change from Baseline on the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score [ Time Frame: Baseline, 104 weeks ]Change from baseline on the ADCS-iADL score.
- Change from Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, 104 weeks ]Change from baseline on the CDR-SB score.
- Change from Baseline on the Mini Mental Status Examination (MMSE) Score [ Time Frame: Baseline, 104 weeks ]Change from baseline on the MMSE score.
- Change from Baseline in Aggregated Tau Deposition [ Time Frame: Baseline, 104 weeks ]Change from baseline in aggregated tau deposition.
- Change from Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 104 weeks ]Change from baseline in brain volume as measured by vMRI.
- Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through Week 104 ]Percentage of participants with suicidal ideation and behaviors assessed by the C-SSRS.
- Number of Participants with Treatment Emergent Anti-LY3303560 Antibodies [ Time Frame: Baseline through Week 113 ]Number of participants with treatment emergent anti-LY3303560 antibodies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518073
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|