A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03367403 |
Recruitment Status :
Active, not recruiting
First Posted : December 8, 2017
Last Update Posted : January 6, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: LY3002813 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 266 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease |
Actual Study Start Date : | December 18, 2017 |
Actual Primary Completion Date : | December 4, 2020 |
Estimated Study Completion Date : | November 12, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: LY3002813
LY3002813 administered intravenously (IV).
|
Drug: LY3002813
Administered IV |
Placebo Comparator: Placebo
Placebo administered IV.
|
Drug: Placebo
Administered IV |
- Change from Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, 18 Months ]Change from baseline in the iADRS score
- Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score [ Time Frame: Baseline, 18 Months ]Change from baseline in the ADAS-Cog13 score
- Change from Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, 18 Months ]Change from baseline in the CDR-SB score
- Change from Baseline in the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, 18 Months ]Change from baseline in the MMSE score
- Change from Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score [ Time Frame: Baseline, 18 Months ]Change from baseline in the ADCS-iADL score
- Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, 18 Months ]Change from baseline in brain amyloid plaque deposition as measured by Florbetapir F18 PET scan
- Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan [ Time Frame: Baseline, 18 Months ]Change from baseline in brain tau deposition as measured by flortaucipir F18 PET scan
- Change from Baseline in Brain Volume as Measured by volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 18 Months ]Change from Baseline in Brain Volume as Measured by vMRI

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
- MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
- Meet 18F flortaucipir PET scan criteria.
- Meet 18F florbetapir PET scan (central read) criteria.
Exclusion Criteria:
- Have a history of long QT syndrome.
- Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
- Contraindication to MRI.

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): NCT03367403

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03367403 |
Other Study ID Numbers: |
16933 I5T-MC-AACG ( Other Identifier: Eli Lilly and Company ) |
First Posted: | December 8, 2017 Key Record Dates |
Last Update Posted: | January 6, 2021 |
Last Verified: | January 1, 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
TRAILBLAZER-ALZ |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |