- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00959192
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
November 30, 2015 updated by: Pfizer
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Aichi, Japan, 451-8511
- Meitetsu Hospital
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Ibaraki, Japan, 309-1793
- Ibaraki Prefectural Central Hospital
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Kanagawa, Japan, 243-8551
- Shonan Atsugi Hospital
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Kanagawa, Japan, 252-0380
- Kitasato University East Hospital
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Osaka, Japan, 530-8480
- Tazuke Kofukai Medical Research Institute Kitano Hospital
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Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Tokyo, Japan, 136-0075
- Juntendo Tokyo Koto Geriatric Medical Center
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Tokyo, Japan, 158-8531
- Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
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Tokyo, Japan, 105-8471
- The Jikei University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of mild to moderate Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 16-26
Exclusion Criteria:
- Significant Neurological Disease other than Alzheimer's disease
- Major psychiatric disorder
- Clinically significant systemic illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACC-001 + QS-21
Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
|
IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
|
Placebo Comparator: QS-21
Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
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IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline up to 24 months
|
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Time Frame: Baseline up to 24 months
|
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 Abnormalities in Neurological Examination
Time Frame: Baseline up to 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-a-beta IgG Titer at Specified Visits
Time Frame: Baseline up to 24 months
|
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
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Baseline up to 24 months
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Anti-a-beta IgM Titer at Specified Visits
Time Frame: Baseline up to 24 months
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Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104
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Baseline up to 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Time Frame: Baseline up to 24 months
|
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility.
For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11.
Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.
|
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.
Time Frame: Baseline up to 24 months
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The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction. |
Baseline up to 24 months
|
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Time Frame: Baseline up to 24 months
|
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function.
The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test.
The NTB z-score is used for analysis.
The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study.
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Baseline up to 24 months
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The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Time Frame: Baseline up to 24 months
|
The MMSE is a brief, structured examination of cognitive function.
It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.
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Baseline up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
August 13, 2009
First Submitted That Met QC Criteria
August 13, 2009
First Posted (Estimate)
August 14, 2009
Study Record Updates
Last Update Posted (Estimate)
January 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3134K1-2206
- B2571009 (Other Identifier: Alias Study Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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