A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

• ClinicalTrials.gov Identifier: NCT03518073
• Recruitment Status: Active, not recruiting
• First Posted: May 8, 2018
• Last Update Posted: October 4, 2019
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease (AD)	Drug: LY3303560; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 285 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: LY3303560 Dose 1; LY3303560 administered intravenously (IV).	Drug: LY3303560; Administered IV
Experimental: LY3303560 Dose 2; LY3303560 administered IV.	Drug: LY3303560; Administered IV
Placebo Comparator: Placebo; Placebo administered IV.	Drug: Placebo; Administered IV

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, 104 weeks ]
   Change from baseline on the iADRS.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. Change from Baseline on the Mini Mental Status Examination (MMSE) Score [ Time Frame: Baseline, 104 weeks ]
   Change from baseline on the MMSE score.
5. Change from Baseline in Aggregated Tau Deposition [ Time Frame: Baseline, 104 weeks ]
   Change from baseline in aggregated tau deposition.
6. 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.
7. 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.
8. Number of Participants with Treatment Emergent Anti-LY3303560 Antibodies [ Time Frame: Baseline through Week 113 ]
   Number of participants with treatment emergent anti-LY3303560 antibodies

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Participants must have gradual and progressive change in memory function for >6 months.
• Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.

Exclusion Criteria:

• Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.
• Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy <24 months.
• Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.
• Participants must not have serious risk for suicide.
• Participants must not have history of drug or alcohol use disorder within the last 2 years.
• Participants must not have multiple severe drug allergies
• Participants must not have HIV, Hepatitis B or Hepatitis C
• Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy

Contacts and Locations

  Show 60 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• 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

More Information

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03518073 History of Changes
• Other Study ID Numbers: 16124; I8G-MC-LMDC ( Other Identifier: Eli Lilly and Company )
• First Posted: May 8, 2018
• Last Update Posted: October 4, 2019
• Last Verified: October 2019

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

Keywords provided by Eli Lilly and Company:

Memory problems; Cognitive impairment; PERISCOPE-ALZ; Dementia; Tauopathy; Neurofibrillary tangles

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders