Phase 2
Completed N=160
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00955409 ↗Enrolled (actual)
160
Serious AEs
20.1%
Results posted
Mar 2021
Primary outcomePrimary: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) — 100.0; 100.0; 93.8; 92.9 percentage of participants
Summary
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) |
100.0; 100.0; 93.8; 92.9; 78.8; 90.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
- Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10
Exclusion Criteria
- Significant Neurological Disease other than Alzheimer's disease
- Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
- Clinically significant systemic illness
Data sourced from ClinicalTrials.gov (NCT00955409). 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.