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

This study has been completed.

Sponsor:

Collaborator:

Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00479557

First received: May 24, 2007

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2007

Last Updated Date

February 15, 2013

Start Date ^ICMJE

May 2007

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess the safety and tolerability of multiple doses of ACC-001 in subjects with mild to moderate AD. [ Time Frame: 2 years participation per patient ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Adverse events and other safety assessment, tolerability, and immunogenicity. [ Time Frame: 2 years participation per patient ]

Change History

Complete list of historical versions of study NCT00479557 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess the immunogenicity of each dose level of ACC-001 with or without QS-21 in subjects with mild to moderate AD. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Cognitive and functional measures

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase IIA, 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 Subjects With Mild To Moderate Alzheimer's Disease

Brief Summary

To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Alzheimer Disease

Intervention ^ICMJE

Biological: ACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Biological: ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
Biological: QS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
Drug: Placebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12

Study Arm (s)

Active Comparator: 1
arm 1: ACC-001 (Vanutide Cridificar)+ QS-21

Intervention: Biological: ACC-001 + QS-21
Active Comparator: 2
arm 2: ACC-001

Intervention: Biological: ACC-001
Placebo Comparator: 3
arm 3: QS-21

Intervention: Biological: QS-21
Placebo Comparator: 4
Drug: Phosphate Buffered Saline (PBS)

Intervention: Drug: Placebo: Phosphate buffered saline

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
Brain MRI consistent with Alzheimer Disease
Concurent use of Chloniesterase inhibitor or memantine allowed if stable
Other inclusion criteria apply

Exclusion Criteria:

Significant Neurological Disease other than Alzheimer's disease
Major psychiatric disorder
Contraindication to undergo brain MRI
Clinically significant systemic illness
Other exclusion criteria apply

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Germany, Spain

Administrative Information

NCT Number ^ICMJE

NCT00479557

Other Study ID Numbers ^ICMJE

3134K1-200, B2571004

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2013

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

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