Clinical trial NCT01238991: Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Official title: A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
First posted: 2010-11-11
Enrollment: 53
Sex: ALL
Minimum age (years): 52
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.


Eligibility criteria: Inclusion Criteria:

* Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
* Screening brain MRI scan is consistent with the diagnosis of AD.
* MMSE score 10 and above.

Exclusion Criteria:

* Significant neurological diseases other than AD.
* Brain MRI evidence of vasogenic edema during the preceding studies.
* Clinically significant illness.

Primary outcomes:
measure: Number 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 of the preceding studies through 24 months of this study
Secondary outcomes:
Other outcomes:
measure: Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
timeFrame: Baseline of preceding studies to month 24 of this study (Week 210)
measure: Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
timeFrame: Baseline of preceding studies to month 24 of this study (Week 210)
measure: The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 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 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 26, 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 12, 26, 36, 52, 66, 78, 91 and 104.
timeFrame: Baseline up to 24 Months
Locations:
city: Nagoya
country: Japan
facility: Meitetsu Hospital
state: Aichi
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital
state: Ibaraki
city: Atsugi
country: Japan
facility: Shonan Atsugi Hospital
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Kitasato University East Hospital
state: Kanagawa
city: Suwa
country: Japan
facility: Suwa Red Cross Hospital
state: Nagano
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
state: Tokyo
city: Minato-ku
country: Japan
facility: The Tokyo Jikei University School of Medicine
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
state: Tokyo
city: Osaka
country: Japan
facility: Tazuke Kofukai Medical Research Institute Kitano Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: