Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
NCT ID: NCT00752232
Last Updated: 2016-01-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2008-12-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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ACC-001+QS-21
Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
ACC-001
Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
QS-21
Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
PBS
Placebo, IM injection, Day 1, month 3, 6, 9, 12
PBS
IM injection, Day 1, month 3, 6, 9, 12
Interventions
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ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
ACC-001
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
QS-21
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
PBS
IM injection, Day 1, month 3, 6, 9, 12
Eligibility Criteria
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Inclusion Criteria
* Mini Mental Status Exam (MMSE) of 16-26
Exclusion Criteria
* Major Psychiatric Disorder
* Clinically significant systemic illness
50 Years
85 Years
ALL
No
Sponsors
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JANSSEN Alzheimer Immunotherapy Research & Development, LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Suwa Red Cross Hospital
Suwa, Nagano, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Meitetsu Hospital
Aichi, , Japan
Ibaraki Prefectural Central Hospital
Ibaraki, , Japan
Shonan Atsugi Hospital
Kanagawa, , Japan
Kitasato University East Hospital
Kanagawa, , Japan
Juntendo University Hospital
Tokyo, , Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, , Japan
Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
Tokyo, , Japan
Countries
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References
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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.
Related Links
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Other Identifiers
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B2571006
Identifier Type: OTHER
Identifier Source: secondary_id
3134K1-2202
Identifier Type: -
Identifier Source: org_study_id
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