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

Last updated on March 22, 2018

FOR MORE INFORMATION
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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Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
  • 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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01227564
B2571010
B2571010
3134K1-2208 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2016

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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