Health Trials

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

ConditionsCognitive DysfunctionLewy Body DiseaseSynucleinopathiesAmyloid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-85
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.

Have least 1 core clinical feature of dementia with Lewy bodies (DLB).

Have a score ≥20 on Montreal Cognitive Assessment (MoCA).

Meet plasma P-tau217 criteria.

Disqualifiers

Have a disease or condition that could interfere with this study or is a current serious or unstable illness.

Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.

Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.

Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Donanemab

    Drug

    Donanemab administered IV

  • Placebo

    Drug

    Placebo administered IV

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Donanemab (LY3002813)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Time frame
Baseline through Week 52

Secondary outcomes

1

Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame
Baseline through Week 52
2

Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)

Time frame
Baseline through Week 52
3

Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)

Time frame
Baseline through Week 52
4

Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)

Time frame
Baseline through Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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