Donanemab in Early Symptomatic Alzheimer’s Disease

Phase 1

• Conditions: Early Symptomatic Alzheimer’s Disease; MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-000077-25-PL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-27
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

-60 to 85 years of age inclusive, at the time of signing the informed consent,
-Gradual and progressive change in memory function reported by the participant or
informant for =6 months,
-An MMSE score of 20 to 28 (inclusive) at LEAD-IN SCREENING or COMPLETE SCREENING,
-An acceptable P-tau criterion, or historical positive AD pathology prior to complete screening,
-Meet flortaucipir F18 scan (central read) criteria,
-Meet florbetapir F18 scan (central read) criteria,
-Have a study partner who will provide written informed consent to participate, is in
frequent contact with the participant (defined as at least 10 hours per week), and will
accompany the participant to study visits or be available by telephone at designated
times,

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1740

Exclusion Criteria

-Significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson’s disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures),
-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 the analyses in this study; or has a life expectancy of <24months,
-History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous
cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread,
-Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant’s ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded,
-History of clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis,and/or exfoliative dermatitis),

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified