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

Alzheimer's Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959192
• Other study ID #: 3134K1-2206
• Secondary ID: B2571009
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2009
• Last updated: November 30, 2015
• Start date: August 2009
• Est. completion date: January 2013

Study information

• Verified date: November 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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
• QS-21
IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12

Locations

Country	Name	City	State
Japan	Meitetsu Hospital	Aichi
Japan	Ibaraki Prefectural Central Hospital	Ibaraki
Japan	Kitasato University East Hospital	Kanagawa
Japan	Shonan Atsugi Hospital	Kanagawa
Japan	Tazuke Kofukai Medical Research Institute Kitano Hospital	Osaka
Japan	Juntendo Tokyo Koto Geriatric Medical Center	Tokyo
Japan	Juntendo University Hospital	Tokyo
Japan	Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache	Tokyo
Japan	The Jikei University School of medicine	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.	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.	Baseline up to 24 months	No
Other	The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.	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.	Baseline up to 24 months	No
Other	The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.	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.	Baseline up to 24 months	No
Other	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.	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.	Baseline up to 24 months	No
Primary	Incidence of Treatment-emergent Adverse Events (AEs) by Severity	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)	Baseline up to 24 months	Yes
Primary	Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data	Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.	Baseline up to 24 months	Yes
Primary	Number of Participants With Abnormalities in Neurological Examination	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.	Baseline up to 24 months	Yes
Secondary	Anti-a-beta IgG Titer at Specified Visits	Geometric mean of anti-a-beta IgG titer from pre-study through Week 104	Baseline up to 24 months	No
Secondary	Anti-a-beta IgM Titer at Specified Visits	Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104	Baseline up to 24 months	No

External Links

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