Phase 2
Completed N=40
Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00752232 ↗Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Jan 2016
Primary outcomePrimary: Incidence of Treatment-emergent Adverse Events (AEs) by Severity — 5; 6; 4; 5 Participants
Summary
The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events (AEs) by Severity |
5; 6; 4; 5; 3; 6 | — |
| PRIMARY Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Abnormalities in Neurological Examination |
2; 0; 1; 0; 0; 0 | — |
| SECONDARY Anti-a-beta IgG Titer at Specified Visits |
50.0; 50.0; 50.0; 50.0; 50.0; 50.0 | — |
| SECONDARY Anti-a-beta IgM Titer at Specified Visits |
25.0; 31.7; 25.0; 32.9; 31.0; 36.1 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of mild to moderate Alzheimer's Disease
- Mini Mental Status Exam (MMSE) of 16-26
Exclusion Criteria
- Significant Neurological Disease
- Major Psychiatric Disorder
- Clinically significant systemic illness
Data sourced from ClinicalTrials.gov (NCT00752232). 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.