Clinical trial NCT00752232: Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
Official title: A Phaseiia, 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 Japanese Subjects With Mild To Moderate Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer Disease
Keywords: Phase IIa
multiple ascending dose study of ACC-001
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2008-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Significant Neurological 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, 36, 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, 36, 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, 36, 52, 78 and 104.
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, 36, 40, 52, 78 and 104.
timeFrame: Baseline up to 24 months
Locations:
city: Suwa
country: Japan
facility: Suwa Red Cross Hospital
state: Nagano
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
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: 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.