Health TrialsbyHealthPanel

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease

ConditionAlzheimer Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-85
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to assess how well Donanemab is tolerated and what side effects may occur in Indian participants with early symptoms of Alzheimer's Disease (AD). For each participant, the study will last up to approximately 84 weeks and will include visits every 4 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gradual and progressive change in memory function reported by the participant or informant for greater than or equal to (≥) 6 months.

Clinical diagnosis of mild cognitive impairment due to Alzheimer's Disease (AD) or mild Alzheimer's dementia.

Evidence of amyloid pathology confirmed by plasma phosphorylated tau217 (P-tau217) levels.

A Mini Mental State Examination (MMSE) score of 20 to 28 (inclusive).

Disqualifiers

Have significant neurological disease affecting the central nervous system other than AD.

Have a condition that in the investigator's opinion could interfere with the analyses of this study.

Have a life expectancy of less than 24 months.

Have a presence or history of malignant neoplasms within the past 5 years.

Trial design

Design model

Single group

Treatments tested in this trial

  • Donanemab

    Drug

    Donanemab administered IV

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: DonanemabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Any Occurrence of Amyloid-Related Imaging Abnormalities (ARIA)

Time frame
Baseline Up to Week 24, 52
2

Frequency and Severity of Infusion-Related Reactions

Time frame
Through Week 52

Secondary outcomes

1

Change from Baseline in Mini Mental State Examination (MMSE) Score

Time frame
Baseline through Week 76
2

Change from Baseline in Plasma Phosphorylated Tau217 (P-tau217)

Time frame
Baseline through Week 76

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

This trial is not recruiting at the moment. You can still explore other options: