ong-Term extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Phase 2
- Conditions
- Alzheimer's disease
- Registration Number
- JPRN-jRCT2080221374
- Lead Sponsor
- Pfizer Japan Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 67
Inclusion Criteria
Subjects randomized under previous 3134K1-2202/2206-JA studies and met all inclusion criteria and none of the exclusion criteria.
Screening brain MRI is consistent with the diagnosis of Alzheimer's disease.
MMSE score 10 and above.
Exclusion Criteria
Significant neurological diseases other than Alzheimer's disease.
Brain MRI evidence of Vasogenic Edema during the preceding studies.
Clinically significant illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Events, Vital signs, Weight, Laboratory tests, ECGs, MRI, Physical and Neurological examinations<br>Summary of the evaluation items will be performed with descriptive statistics by treatment group.
- Secondary Outcome Measures
Name Time Method Immunogenicity: (IgG, IgM, IgG subtypes)<br>Efficacy: (ADAS-C0g, DAD, NTB, MMSE)<br>Summary of the change from baseline will be performed by treatment group.