Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
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
2 other identifiers
interventional
53
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2010
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
December 22, 2014
CompletedDecember 22, 2014
December 1, 2014
3 years
October 21, 2010
December 12, 2014
December 12, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Treatment Emergent Adverse Events (AEs) by Severity
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)
Baseline up to 24 months
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Baseline up to 24 months
Number of Participants With Abnormalities in Neurological Examination
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.
Baseline of the preceding studies through 24 months of this study
Other Outcomes (6)
Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Baseline of preceding studies to month 24 of this study (Week 210)
Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Baseline of preceding studies to month 24 of this study (Week 210)
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
Baseline up to 24 Months
- +3 more other outcomes
Study Arms (3)
ACC-001 (3 micrograms) + QS-21
EXPERIMENTALActive vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
ACC-001 (10 micrograms) + QS-21
EXPERIMENTALActive vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
ACC-001 (30 micrograms) + QS-21
EXPERIMENTALActive vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Interventions
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
Eligibility Criteria
You may not qualify if:
- Screening brain MRI scan is consistent with the diagnosis of AD.
- MMSE score 10 and above.
- Significant neurological diseases other than AD.
- Brain MRI evidence of vasogenic edema during the preceding studies.
- Clinically significant illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Meitetsu Hospital
Nagoya, Aichi-ken, 451-8511, Japan
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 309-1793, Japan
Shonan Atsugi Hospital
Atsugi, Kanagawa, 243-8551, Japan
Kitasato University East Hospital
Sagamihara-shi, Kanagawa, 252-0380, Japan
Suwa Red Cross Hospital
Suwa, Nagano, 392-8510, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, 530-8480, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, 569-8686, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, 136-0075, Japan
The Tokyo Jikei University School of Medicine
Minato-ku, Tokyo, 105-8471, Japan
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
Setagaya-ku, Tokyo, 158-8531, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Since the study was early terminated and the data could not be obtained as planned, only part of the immunogenicity and safety results were summarized.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2010
First Posted
November 11, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 22, 2014
Results First Posted
December 22, 2014
Record last verified: 2014-12