Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT01238991|
Recruitment Status : Terminated
First Posted : November 11, 2010
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Biological: ACC-001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: ACC-001 (3 micrograms) + QS-21
Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
Experimental: ACC-001 (10 micrograms) + QS-21
Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
Experimental: ACC-001 (30 micrograms) + QS-21
Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
- 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 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 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.
- Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits [ Time Frame: Baseline of preceding studies to month 24 of this study (Week 210) ]Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study
- Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits [ Time Frame: Baseline of preceding studies to month 24 of this study (Week 210) ]Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study
- The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 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, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).
- The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104. [ Time Frame: Baseline up to 24 Months ]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.
- The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104. [ 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.
- The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 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, and any score equal to or lower than 26 points indicates cognitive impairment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238991
|Nagoya, Aichi, Japan, 451-8511|
|Ibaraki Prefectural Central Hospital|
|Kasama, Ibaraki, Japan, 309-1793|
|Shonan Atsugi Hospital|
|Atsugi, Kanagawa, Japan, 243-8551|
|Kitasato University East Hospital|
|Sagamihara-shi, Kanagawa, Japan, 252-0380|
|Suwa Red Cross Hospital|
|Suwa, Nagano, Japan, 392-8510|
|Osaka Medical College Hospital|
|Takatsuki, Osaka, Japan, 569-8686|
|Juntendo University Hospital|
|Bunkyo-ku, Tokyo, Japan, 113-8431|
|Juntendo Tokyo Koto Geriatric Medical Center|
|Koto-ku, Tokyo, Japan, 136-0075|
|The Tokyo Jikei University School of Medicine|
|Minato-ku, Tokyo, Japan, 105-8471|
|Kanto Central Hospital of the Mutual Aid Association of Public School Teachers|
|Setagaya-ku, Tokyo, Japan, 158-8531|
|Tazuke Kofukai Medical Research Institute Kitano Hospital|
|Osaka, Japan, 530-8480|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|