Clinical trial

Donanemab Follow-On Study: Safety, Tolerability, And Efficacy in Symptomatic Alzheimer's Disease With Validation of Remote Neuropsychological Assessments

Name

17447

Description

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate video scale assessments.

Trial arms

Trial start

2020-11-23

Estimated PCD

2024-02-27

Trial end

2024-02-27

Status

Completed

Phase

Early phase I

Treatment

No Intervention

No intervention

Arms:

Part A Validation of Remote Scale Assessments

donanemab

Administered IV

Arms:

Part B Donanemab

Other names:

LY3002813

Size

Primary endpoint

Part A: Correlation between VTC and on-site assessment for PAIR 1 for Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)

1 Month

Part A: Correlation between VTC and on-site assessment for PAIR 1 for Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

1 Month

Part A: Correlation between VTC and on-site assessment for PAIR 1 for Mini Mental State Examination (MMSE) Score

1 Month

Part A: Correlation between VTC and on-site assessment for PAIR 1 for Clinical Dementia Rating-Sum of Boxes (CDR-SB)

1 Month

Part B: Percentage of Participants with One or More Adverse Events (AEs) or Serious AEs

Up to 72 Weeks

Eligibility criteria

Inclusion Criteria: * Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study. * Have a study partner * Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A Exclusion Criteria: * Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study. * Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study. * Poor venous access * Contraindication to PET or MRI imaging

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 94, 'type': 'ACTUAL'}}

Updated at

2024-04-23

1 organization

2 products

5 indications

Organization

Eli Lilly and Company

Product

donanemab

Indication

Alzheimer's disease

Indication