Clinical trial NCT00479557: Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
active immunization
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
First posted: 2007-05-28
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
timeFrame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.
Secondary outcomes:
measure: 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
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
measure: 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
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
measure: 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)
timeFrame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
state: Cedex 13 (MRI)
city: Paris Cedex 13
country: France
facility: Hôpital Pitié-Salpétrière
state: Paris
city: Bordeaux
country: France
facility: Hopital Pellegrin-Centre Mémoire de Recherche et de Ressources
city: Lille (MRI)
country: France
facility: CHRU de Lille
city: Lille
country: France
facility: CHRU de Lille
city: MARSEILLE cedex 5
country: France
facility: Hôpital Sainte-Marguerite
city: Montpellier
country: France
facility: CHU Hôpital Gui de Chaulliac
city: Paris
country: France
facility: Groupe Hospitalier Broca-La Rochefoucauld
city: St JEAN
country: France
facility: Clinique de L'Union
city: TOULOUSE Cedex 9
country: France
facility: Hôpital LA GRAVE
city: Toulouse
country: France
facility: Chru Purpan
city: Toulouse
country: France
facility: Clinique PASTEUR
city: Freiburg
country: Germany
facility: Unversitätsklinikum Freiburg
state: Baden- Württemberg
city: Berlin
country: Germany
facility: Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
city: Frankenthal
country: Germany
facility: Zentralinstitut fuer Seelische Gesundheit
city: Goettingen
country: Germany
facility: Klinik fuer Psychiatrie und Psychotherapie
city: Mannheim
country: Germany
facility: Zentralinstitut fuer Seelische Gesundheit
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: München
country: Germany
facility: Technische Universitaet Muenchen, Klinikum rechts der Isar
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinico y Provincial
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.