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Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00752232
First received: September 11, 2008
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Alzheimer Disease
Biological: ACC-001
Other: QS-21
Other: PBS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

  • 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 investigator.

  • Number of Participants With Abnormalities in Neurological Examination [ Time Frame: Baseline up to 24 months ] [ 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 Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.


Secondary Outcome Measures:
  • Anti-a-beta IgG Titer at Specified Visits [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    Geometric mean of anti-a-beta IgG titer from pre-study through Week 104

  • Anti-a-beta IgM Titer at Specified Visits [ Time Frame: Baseline up to 24 months ] [ Designated as safety issue: No ]
    Geometric mean of anti-a-beta IgM titer from pre-study through Week 104


Other Outcome Measures:
  • 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. [ 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 stuy, 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.

  • The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 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 12, 26, 36, 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), WMSVerbal 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 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 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 (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.


Enrollment: 40
Study Start Date: December 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACC-001+QS-21
Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Biological: ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Other: QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Experimental: ACC-001
Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Biological: ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Placebo Comparator: QS-21
Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Other: QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Placebo Comparator: PBS
Placebo, IM injection, Day 1, month 3, 6, 9, 12
Other: PBS
IM injection, Day 1, month 3, 6, 9, 12

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of mild to moderate Alzheimer's Disease
  • Mini Mental Status Exam (MMSE) of 16-26

Exclusion Criteria:

  • Significant Neurological Disease
  • Major Psychiatric Disorder
  • Clinically significant systemic 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: NCT00752232

Locations
Japan
Suwa Red Cross Hospital
Suwa, Nagano, Japan, 392-8510
Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 569-8686
Meitetsu Hospital
Aichi, Japan, 451-8511
Ibaraki Prefectural Central Hospital
Ibaraki, Japan, 309-1793
Shonan Atsugi Hospital
Kanagawa, Japan, 243-8551
Kitasato University East Hospital
Kanagawa, Japan, 252-0380
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Japan, 530-8480
Juntendo University Hospital
Tokyo, Japan, 113-8431
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, Japan, 136-0075
Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
Tokyo, Japan, 158-8531
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00752232     History of Changes
Other Study ID Numbers: 3134K1-2202  B2571006 
Study First Received: September 11, 2008
Results First Received: May 9, 2014
Last Updated: November 30, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Phase IIa
multiple ascending dose study of ACC-001

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016