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

Alzheimer Disease Clinical Trial

Official title:

A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955409
• Other study ID #: 3134K1-2203
• Secondary ID: B25710072009-010
• Status: Completed
• Phase: Phase 2
• Start date: November 5, 2009
• Est. completion date: December 17, 2013

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 17, 2013
• Est. primary completion date: December 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria

• Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score =10

Exclusion Criteria:

• Significant Neurological Disease other than Alzheimer's disease

• Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)

• Clinically significant systemic illness

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• ACC-001(3µg) + QS21
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
• ACC-001(10µg) + QS21
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
• ACC-001(30µg) + QS21
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

Locations

Country	Name	City	State
France	CMRR Bordeaux CHU Pellegrin	Bordeaux Cedex
France	Hopital Roger Salengro	Lille
France	Hôpital Roger Salengro	Lille
France	CHU La Timone	Marseille cedex 5
France	Groupe Hospitalier Broca-La Rochefoucauld	Paris
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Hôpital Pitié-Salpétrière	Paris Cedex 13
France	Hôpital La Grave	Toulouse cedex 9
Germany	Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin	Berlin
Germany	Universitatsklinikum und Poliklinik der Uni Bonn	Bonn
Germany	Klinikum der Albert-Ludwigs-Universitaet Freiburg	Freiburg
Germany	Klinik fuer Psychiatrie und Psychotherapie	Goettingen
Germany	Zentralinstitut fuer Seelische Gesundheit Mannheim	Mannheim
Germany	Technische Universität München	Munich
Spain	Hospital Clinico y Provincial	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona

Sponsors (2)

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

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	IGM was not statistically analyzed.	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Other	Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)	IgG subtypes were not assessed	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Other	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Primary	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	24 months

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