Phase 2
Completed N=32
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00959192 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Incidence of Treatment-emergent Adverse Events (AEs) by Severity — 4; 7; 7; 5 Participants
Summary
The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events (AEs) by Severity |
4; 7; 7; 5; 2; 1 | — |
| PRIMARY Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data |
1; 0; 2; 0; 6; 9 | — |
| PRIMARY Number of Participants With Abnormalities in Neurological Examination |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Anti-a-beta IgG Titer at Specified Visits |
50.0; 50.0; 50.0; 50.0; 62.2; 65.0 | — |
| SECONDARY Anti-a-beta IgM Titer at Specified Visits |
30.9; 28.2; 25.0; 41.5; 77.1; 92.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of mild to moderate Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 16-26
Exclusion Criteria
- Significant Neurological Disease other than Alzheimer's disease
- Major psychiatric disorder
- Clinically significant systemic illness
Data sourced from ClinicalTrials.gov (NCT00959192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.