A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Pfizer
- Enrollment
- 53
- Locations
- 11
- Primary Endpoint
- Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Study Overview
Brief Summary
The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 52 Years to 87 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the
Exclusion Criteria
- •Screening brain MRI scan is consistent with the diagnosis of AD.
- •MMSE score 10 and above.
- •Exclusion Criteria:
- •Significant neurological diseases other than AD.
- •Brain MRI evidence of vasogenic edema during the preceding studies.
- •Clinically significant illness.
Arms & Interventions
ACC-001 (30 micrograms) + QS-21
Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Intervention: ACC-001 (Biological)
ACC-001 (10 micrograms) + QS-21
Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Intervention: ACC-001 (Biological)
ACC-001 (3 micrograms) + QS-21
Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Intervention: ACC-001 (Biological)
Outcomes
Primary Outcomes
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Time Frame: Baseline up to 24 months
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Number of Treatment Emergent Adverse Events (AEs) by Severity
Time Frame: Baseline up to 24 months
Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Number of Participants With Abnormalities in Neurological Examination
Time Frame: Baseline of the preceding studies through 24 months of this study
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
Secondary Outcomes
No secondary outcomes reported