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Trial record 1 of 1 for:    NCT00752232
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Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00752232
Recruitment Status : Completed
First Posted : September 15, 2008
Results First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 11, 2008
First Posted Date  ICMJE September 15, 2008
Results First Submitted Date  ICMJE May 9, 2014
Results First Posted Date  ICMJE January 1, 2016
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE December 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • 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)
  • 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 investigator.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2008)
Adverse Events and Tolerability [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • 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
  • Anti-a-beta IgM Titer at Specified Visits [ Time Frame: Baseline up to 24 months ]
    Geometric mean of anti-a-beta IgM titer from pre-study through Week 104
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2008)
Cognitive and functional measures [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2015)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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
  • Other: PBS
    IM injection, Day 1, month 3, 6, 9, 12
Study Arms  ICMJE
  • Experimental: ACC-001+QS-21
    Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
    Interventions:
    • Biological: ACC-001
    • Other: QS-21
  • Experimental: ACC-001
    Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
    Intervention: Biological: ACC-001
  • Placebo Comparator: QS-21
    Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
    Intervention: Other: QS-21
  • Placebo Comparator: PBS
    Placebo, IM injection, Day 1, month 3, 6, 9, 12
    Intervention: Other: PBS
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00752232
Other Study ID Numbers  ICMJE 3134K1-2202
B2571006 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP