A Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study

NCT01230853 | Completed Phase 1

• 1 other identifier: BAN2401-A001-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 8

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).

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Single Ascending Dose (SAD)

  To evaluate the safety and tolerability of single intravenous (i.v.) infusions of lecanemab at sequentially ascending doses in subjects with mild to moderate Alzheimer's disease (AD)

  baseline to Day 180 post-dose

• Multiple Ascending Dose(MAD)

  To evaluate the safety and tolerability of 4 monthly i.v. infusions of lecanemab at sequentially ascending doses in subjects with AD

  baseline to Day 264 post-dose

Study Arms (4)

Active Comparator: A

ACTIVE COMPARATOR

Drug: Active Comparator: A

Placebo Comparator A

PLACEBO COMPARATOR

Drug: Placebo Comparator A

Active Comparator: B

ACTIVE COMPARATOR

Drug: Active Comparator B

Placebo Comparator B

PLACEBO COMPARATOR

Drug: Placebo Comparator B

Interventions

Active Comparator: A DRUG

Lecanemab Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)

Also known as: BAN2401

Active Comparator: A

Placebo Comparator B DRUG

Placebo Matching Placebo Infusion

Placebo Comparator B

Active Comparator B DRUG

Lecanemab Multiple Dose Ascending Intravenous infusions once every 4 weeks at sequentially ascending doses (dose levels: 0.3, 1, 3, and 10 mg/kg)

Also known as: BAN2401

Active Comparator: B

Placebo Comparator A DRUG

Placebo Matching Placebo Infusion

Placebo Comparator A

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (8)

Unknown Facility

Garden Grove, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Eatontown, New Jersey, United States

Location

Unknown Facility

Princeton, New Jersey, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Related Publications (1)

• 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.

  PMID: 27048170 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Eisai Medical Services

  Eisai Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 29, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 23, 2020

Record last verified: 2013-02

Locations

US (8)