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Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

Last updated on January 21, 2020

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Study Location
Banner Alzheimer's Institute
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Concern about a change in cognition expressed by the subject or by an informant that
knows the subject well

- Mini-Mental State Examination (MMSE) score ≥ 25

- Global Clinical Dementia Rating = 0.5.

- General cognition and functional performance sufficiently preserved such that a
diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time
of screening.

- Amyloid burden detected on screening brain PET scan.

- Other inclusion criteria apply.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Significant neurological disease other than early Alzheimer's disease

- Major psychiatric disorder or symptom

- Contraindication to undergo brain MRI

- Unstable medical conditions

- Other exclusion criteria apply

NCT01227564
Pfizer
Completed
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

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Descriptive Information
Brief Title  ICMJE Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
Official Title  ICMJE A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.
Brief Summary This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Biological: ACC-001 3 ?g/ QS-21 50 ?g
    ACC-001 3 ?g/ QS-21 50 ?g IM on day 1, month 1, month 3, month 6, month 12, and month 18
    Other Name: Vanutide Cridificar
  • Biological: ACC-001 10 ?g/ QS-21 50 ?g
    ACC-001 10 ?g/ QS-21 50 ?g IM on day 1, month 1, month 3, month 6, month 12, and month 18
    Other Name: Vanutide Cridificar
  • Other: Placebo- Phosphate buffered saline (PBS)
    Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18
Study Arms  ICMJE
  • Experimental: ACC-001 3 ?g/ QS-21 50 ?g
    Intervention: Biological: ACC-001 3 ?g/ QS-21 50 ?g
  • Experimental: ACC-001 10 ?g/ QS-21 50 ?g
    Intervention: Biological: ACC-001 10 ?g/ QS-21 50 ?g
  • Placebo Comparator: Placebo- Phosphate buffered saline (PBS)
    Intervention: Other: Placebo- Phosphate buffered saline (PBS)
Publications * van Dyck CH, Sadowsky C, Le Prince Leterme G, Booth K, Peng Y, Marek K, Ketter N, Liu E, Wyman BT, Jackson N, Slomkowski M, Ryan JM. Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Individuals with Early Alzheimer's Disease: Amyloid Imaging Positron Emission Tomography and Safety Results from a Phase 2 Study. J Prev Alzheimers Dis. 2016;3(2):75-84. doi: 10.14283/jpad.2016.91.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2012)
63
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2010)
108
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
  • Mini-Mental State Examination (MMSE) score ? 25
  • Global Clinical Dementia Rating = 0.5.
  • General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
  • Amyloid burden detected on screening brain PET scan.
  • Other inclusion criteria apply.

Exclusion Criteria:

  • Significant neurological disease other than early Alzheimer's disease
  • Major psychiatric disorder or symptom
  • Contraindication to undergo brain MRI
  • Unstable medical conditions
  • Other exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01227564
Other Study ID Numbers  ICMJE B2571010
B2571010
3134K1-2208 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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