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, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479557
• Other study ID #: 3134K1-200
• Secondary ID: B25710042006-002
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2007
• Last updated: November 30, 2015
• Start date: May 2007
• Est. completion date: January 2013

Study information

• Verified date: November 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutSpain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• 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 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

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

Intervention

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
• ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
• 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

Locations

Country	Name	City	State
France	Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources	Bordeaux
France	CHRU de Lille	Lille
France	CHRU de Lille	Lille (MRI)
France	Hôpital Sainte-Marguerite	MARSEILLE cedex 5
France	CHU Hôpital Gui de Chaulliac	Montpellier
France	Groupe Hospitalier Broca-La Rochefoucauld	Paris
France	Groupe Hospitalier Pitie-Salpetriere	Paris	Cedex 13 (MRI)
France	Hôpital Pitié-Salpétrière	Paris Cedex 13	Paris
France	Clinique de L'Union	St JEAN
France	Chru Purpan	Toulouse
France	Clinique PASTEUR	Toulouse
France	Hôpital LA GRAVE	TOULOUSE Cedex 9
Germany	Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin	Berlin
Germany	Zentralinstitut fuer Seelische Gesundheit	Frankenthal
Germany	Unversitätsklinikum Freiburg	Freiburg	Baden- Württemberg
Germany	Klinik fuer Psychiatrie und Psychotherapie	Goettingen
Germany	Zentralinstitut fuer Seelische Gesundheit	Mannheim
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Technische Universitaet Muenchen, Klinikum rechts der Isar	München
Spain	Hospital Clinico y Provincial	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Clinico San Carlos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.	Yes
Secondary	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, 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.	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	No
Secondary	GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	No
Secondary	Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)	IgG subtypes were not assessed	Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104	No

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