Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
A Phaseiia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.
2 other identifiers
interventional
40
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 alzheimer-disease
Started Dec 2008
Typical duration for phase_2 alzheimer-disease
10 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
September 11, 2008
CompletedFirst Posted
Study publicly available on registry
September 15, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
January 1, 2016
CompletedJanuary 1, 2016
November 1, 2015
3.6 years
September 11, 2008
May 9, 2014
November 30, 2015
Conditions
Keywords
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 investigator.
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, 36, 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, 36, 52, 78 and 104.
Baseline up to 24 months
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.
Baseline up to 24 months
- +1 more other outcomes
Study Arms (4)
ACC-001+QS-21
EXPERIMENTALActive vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
ACC-001
EXPERIMENTALActive vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
QS-21
PLACEBO COMPARATORAdjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
PBS
PLACEBO COMPARATORPlacebo, IM injection, Day 1, month 3, 6, 9, 12
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of mild to moderate Alzheimer's Disease
- Mini Mental Status Exam (MMSE) of 16-26
You may not qualify if:
- Significant Neurological Disease
- Major Psychiatric Disorder
- Clinically significant systemic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
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
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
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2008
First Posted
September 15, 2008
Study Start
December 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
January 1, 2016
Results First Posted
January 1, 2016
Record last verified: 2015-11