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Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01238991
First received: October 21, 2010
Last updated: September 17, 2014
Last verified: September 2014

October 21, 2010
September 17, 2014
December 2010
December 2013   (final data collection date for primary outcome measure)
  • Incidence and severity of Treatment Emergent Adverse Events [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • Clinically important changes in safety assessment results, including AEs, vital signs, weight, laboratory tests, ECGs MRI, physical and neurological examinations [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01238991 on ClinicalTrials.gov Archive Site
  • Anti-a-beta IgG (Immunoglobin G) titer at specified visits [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Anti-a-beta IGM (Immunoglobin M) titer at specified visits [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Anti-a-beta IgG subtypes titer if applicable, at specified visits [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Behavior) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of DAD (Disability Assessment for Dementia) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of NTB (Neuropsychiatric Test Battery) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of MMSE (Mini-Mental State Examination) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of anti-a-beta IgG (Immunoglobin G) from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of anti-a-beta IGM (Immunoglobin M) from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of anti-a-beta IgG subtypes if applicable, from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Behavior) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of DAD (Disability Assessment for Dementia) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of NTB (Neuropsychiatric Test Battery) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Changes of MMSE (Mini-Mental State Examination) scores from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: ACC-001
    IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
  • Biological: ACC-001
    IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
  • Biological: ACC-001
    IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
  • Experimental: ACC-001 (3 micrograms) + QS-21
    Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
    Intervention: Biological: ACC-001
  • Experimental: ACC-001 (10 micrograms) + QS-21
    Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
    Intervention: Biological: ACC-001
  • Experimental: ACC-001 (30 micrograms) + QS-21
    Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
    Intervention: Biological: ACC-001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
53
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
52 Years to 87 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01238991
B2571001, 3134K1-2207
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP