Clinical trial NCT01230853: A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study
Official title: A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of BAN2401 in Subjects With Mild to Moderate Alzheimer?s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 multiple dose ascending (MAD) parts designed to allow the MAD part to be initiated while the SAD part is ongoing.

Eligibility criteria: Inclusion:

1. 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.
2. 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.
3. 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.
4. On stable doses of all other prescribed medications for at least 4 weeks prior to the screening visit.

Exclusion:

1. Any neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's disease (AD).
2. Any psychiatric diagnosis or symptoms, e.g hallucinations, major depression, or delusions, that could interfere with assessment of cognition in the subject.
3. History of transient ischemic attack (TIA), stroke, or seizures within 12 months of Screening.
4. 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.
5. 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.

Primary outcomes:
measure: Single Ascending Dose (SAD)
timeFrame: baseline to Day 180 post-dose
measure: Multiple Ascending Dose(MAD)
timeFrame: baseline to Day 264 post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Eatontown
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Eisai Limited
name: Eisai Medical Services
role: STUDY_DIRECTOR
References:
citation: Logovinsky V, Satlin A, Lai R, Swanson C, Kaplow J, Osswald G, Basun H, Lannfelt L. Safety and tolerability of BAN2401--a clinical study in Alzheimer's disease with a protofibril selective Abeta antibody. Alzheimers Res Ther. 2016 Apr 6;8(1):14. doi: 10.1186/s13195-016-0181-2.