Status:
COMPLETED
A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
Lead Sponsor:
Eisai Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The purpose of this study will be to evaluate the safety and tolerability of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD).
Detailed Description
This will be a multicenter, double-blind, randomized, placebo-controlled study in subjects with mild to moderate Alzheimer's disease. The study will comprise separate single dose ascending (SAD) and m...
Eligibility Criteria
Inclusion
- Inclusion:
- Clinical diagnosis of probable mild to moderate Alzheimer's disease (AD) by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association Alzheimer's (NINCDS-ADRDA) criteria.
- A Mini Mental State Examination (MMSE) score of 16 to 28, inclusive, at Screening. Subjects recruited to the first 2 SAD cohorts should have an MMSE of \> 22.
- Where symptomatic treatment of Alzheimer's disease (AD) is clinically indicated, subjects must be on stable treatment (e.g., with an anticholinesterase inhibitor \[AChEI\] and/or memantine) for at least 12 weeks prior to the Screening visit.
- On stable doses of all other prescribed medications for at least 4 weeks prior to the screening visit.
- Exclusion:
- Any neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's disease (AD).
- Any psychiatric diagnosis or symptoms, e.g hallucinations, major depression, or delusions, that could interfere with assessment of cognition in the subject.
- History of transient ischemic attack (TIA), stroke, or seizures within 12 months of Screening.
- Evidence of infection, tumor, stroke or other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain magnetic resonance imaging (MRI) at Screening.
- Other significant pathological findings on brain MRI at Screening, including but not limited to: more than 3 micro-hemorrhages, single macro-hemorrhage; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations or space occupying lesions.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01230853
Start Date
August 1 2010
End Date
February 1 2013
Last Update
November 23 2020
Active Locations (8)
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1
Garden Grove, California, United States
2
San Francisco, California, United States
3
Orlando, Florida, United States
4
Atlanta, Georgia, United States