Clinical trial NCT00959192: Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Official title: Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2009-08-14
Enrollment: 32
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: The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 16-26

Exclusion Criteria:

* Significant Neurological Disease other than Alzheimer's disease
* Major psychiatric disorder
* Clinically significant systemic illness

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (AEs) by Severity
timeFrame: Baseline up to 24 months
measure: Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
timeFrame: Baseline up to 24 months
measure: Number of Participants With Abnormalities in Neurological Examination
timeFrame: Baseline up to 24 months
Secondary outcomes:
measure: Anti-a-beta IgG Titer at Specified Visits
timeFrame: Baseline up to 24 months
measure: Anti-a-beta IgM Titer at Specified Visits
timeFrame: Baseline up to 24 months
Other outcomes:
measure: The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
timeFrame: Baseline up to 24 months
measure: The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
timeFrame: Baseline up to 24 months
measure: The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
timeFrame: Baseline up to 24 months
measure: The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
timeFrame: Baseline up to 24 months
Locations:
city: Aichi
country: Japan
facility: Meitetsu Hospital
city: Ibaraki
country: Japan
facility: Ibaraki Prefectural Central Hospital
city: Kanagawa
country: Japan
facility: Shonan Atsugi Hospital
city: Kanagawa
country: Japan
facility: Kitasato University East Hospital
city: Osaka
country: Japan
facility: Tazuke Kofukai Medical Research Institute Kitano Hospital
city: Tokyo
country: Japan
facility: The Jikei University School of medicine
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
city: Tokyo
country: Japan
facility: Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121.