A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease

• Registration Number: JPRN-jRCT2080223117
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Key Inclusion Criteria for Mild Cognitive Impairment due to Alzheimer's Disease

- Intermediate likelihood:

1.Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease - intermediate likelihood
2.Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
3.Subjects who report a history of subjective memory decline with gradual onset and slow progression over the last one year before Screening; MUST be corroborated by an informant
Key Inclusion Criteria for Mild Alzheimer's Disease Dementia:

4.Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
5.Subjects who have a CDR score of 0.5-1.0 and a Memory Box score of 0.5 or greater at Screening and Baseline
Inclusion Criteria that must be met by all subjects:

6.Subjects with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale - IV Logical Memory II (WMS-IV LMII):

a.Less than or equal to 15 for age 50 to 64 years
b.Less than or equal to 12 for age 65 to 69 years
c.Less than or equal to 11 for age 70 to 74 years
d.Less than or equal to 9 for age 75 to 79 years
e.Less than or equal to 7 for age 80 to 90 years
7.Positive amyloid load as indicated by PET or CSF assessment
8.Age between 50 and 90 years, inclusive
9.Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
10.Body Mass Index (BMI) greater than 17 and less than 35 at Screening
11.Females must not be pregnant or lactating, and specified contraceptive precautions must be followed
12.Subjects on acetylcholinesterase inhibitor or memantine therapy for Alzheimer's disease (AD) must be on a stable dose for at least 12 weeks prior to baseline
13.Subjects must have identified caregivers/informants
14.Subjects must provide written informed consent

Exclusion Criteria

1.Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD
2.History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
3.Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
4.Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants, e,g., in skull and cardiac devices other than those approved as safe for use in MR scanners
5.Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
6.A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
7.Certain other specified medical conditions
8.Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately

Study & Design

• Study Type: Interventional
• Study Design: Not specified