Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects 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:
NCT00959192
First received: August 13, 2009
Last updated: November 30, 2015
Last verified: November 2015

August 13, 2009
November 30, 2015
August 2009
January 2013   (final data collection date for primary outcome measure)
  • 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 radiologists.
  • 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.
Primary Outcome Measures: Incidence and severity of treatment-emergent adverse events (TEAEs); Clinically important changes in safety assessment results (including AEs, vital signs, clinical laboratory tests, ECGs, MRI, physical and neurological exam) [ Time Frame: 2 years participation per patient ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00959192 on ClinicalTrials.gov Archive Site
  • 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 ]
    Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104
Secondary Outcome Measures: Change from baseline levels of anti A-beta immunoglobulin G (IgG). The change from baseline scores for the ADAS-Cog, DAD, NTB, MMSE. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ 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. 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, 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, 52 and 78. [ 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 4, 8, 12, 16, 26, 30, 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.
Not Provided
 
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: ACC-001
    IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
  • Other: QS-21
    IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
  • Other: QS-21
    IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
  • 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
    Interventions:
    • Biological: ACC-001
    • Other: QS-21
  • Placebo Comparator: QS-21
    Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
    Intervention: Other: QS-21
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00959192
3134K1-2206, B2571009
Yes
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2015

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