Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01238991
First received: October 21, 2010
Last updated: December 12, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Biological: ACC-001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Treatment Emergent Adverse Events (AEs) by Severity [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits [ Time Frame: Baseline of preceding studies to month 24 of this study (Week 210) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 53
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACC-001 (3 micrograms) + QS-21
Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
Biological: ACC-001
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
Biological: ACC-001
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
Biological: ACC-001
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18

  Eligibility

Ages Eligible for Study:   52 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
  • Screening brain MRI scan is consistent with the diagnosis of AD.
  • MMSE score 10 and above.

Exclusion Criteria:

  • Significant neurological diseases other than AD.
  • Brain MRI evidence of vasogenic edema during the preceding studies.
  • Clinically significant illness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238991

Locations
Japan
Meitetsu Hospital
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
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01238991     History of Changes
Other Study ID Numbers: B2571001, 3134K1-2207
Study First Received: October 21, 2010
Results First Received: December 12, 2014
Last Updated: December 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on July 30, 2015