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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01238991
• Other study ID #: B2571001
• Secondary ID: 3134K1-2207
• Status: Terminated
• Phase: Phase 2
• First received: October 21, 2010
• Last updated: December 12, 2014
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 52 Years to 87 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• ACC-001
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
• ACC-001
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
• ACC-001
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18

Locations

Country	Name	City	State
Japan	Shonan Atsugi Hospital	Atsugi	Kanagawa
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Ibaraki Prefectural Central Hospital	Kasama	Ibaraki
Japan	Juntendo Tokyo Koto Geriatric Medical Center	Koto-ku	Tokyo
Japan	The Tokyo Jikei University School of Medicine	Minato-ku	Tokyo
Japan	Meitetsu Hospital	Nagoya	Aichi
Japan	Tazuke Kofukai Medical Research Institute Kitano Hospital	Osaka
Japan	Kitasato University East Hospital	Sagamihara-shi	Kanagawa
Japan	Kanto Central Hospital of the Mutual Aid Association of Public School Teachers	Setagaya-ku	Tokyo
Japan	Suwa Red Cross Hospital	Suwa	Nagano
Japan	Osaka Medical College Hospital	Takatsuki	Osaka

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	Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits	Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study	Baseline of preceding studies to month 24 of this study (Week 210)	No
Other	Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits	Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study	Baseline of preceding studies to month 24 of this study (Week 210)	No
Other	The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 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, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).	Baseline up to 24 Months	No
Other	The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 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 26, 52, 78 and 104.	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 12, 26, 36, 52, 66, 78, 91 and 104.	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.	Baseline up to 24 Months	No
Primary	Number of Treatment Emergent Adverse Events (AEs) by Severity	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)	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 Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.	Baseline of the preceding studies through 24 months of this study	Yes

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