Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.
2 other identifiers
interventional
32
1 country
9
Brief 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.
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 Aug 2009
Typical duration for phase_2
9 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
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
January 1, 2016
CompletedJanuary 1, 2016
November 1, 2015
3.4 years
August 13, 2009
May 9, 2014
November 30, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Number of participants who experienced mild, moderate, or 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 Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
Baseline up to 24 months
Secondary Outcomes (2)
Anti-a-beta IgG Titer at Specified Visits
Baseline up to 24 months
Anti-a-beta IgM Titer at Specified Visits
Baseline up to 24 months
Other Outcomes (4)
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Baseline up to 24 months
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Baseline up to 24 months
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Baseline up to 24 months
- +1 more other outcomes
Study Arms (2)
ACC-001 + QS-21
EXPERIMENTALActive vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21
PLACEBO COMPARATORAdjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of mild to moderate Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 16-26
You may not qualify if:
- Significant Neurological Disease other than Alzheimer's disease
- Major psychiatric disorder
- Clinically significant systemic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, 530-8480, Japan
Meitetsu Hospital
Aichi, 451-8511, Japan
Ibaraki Prefectural Central Hospital
Ibaraki, 309-1793, Japan
Shonan Atsugi Hospital
Kanagawa, 243-8551, Japan
Kitasato University East Hospital
Kanagawa, 252-0380, Japan
The Jikei University School of medicine
Tokyo, 105-8471, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, 136-0075, Japan
Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
Tokyo, 158-8531, Japan
Related Publications (1)
Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121.
PMID: 25731629DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 14, 2009
Study Start
August 1, 2009
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 1, 2016
Results First Posted
January 1, 2016
Record last verified: 2015-11