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Eligibility
for people ages 50 years to 85 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose.

Official Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease

Keywords

Alzheimer's Disease

Eligibility

You can join if…

Open to people ages 50 years to 85 years

  • Weight between 40 and 120 kilograms (Kg) inclusive
  • Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
  • Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities,agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
  • Fluency in the language of the tests used at the study site
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
  • Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
  • Demonstrated abnormal memory function at screening
  • Screening mini mental state examination (MMSE) score of greater than or equal to (>=)22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
  • Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
  • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening

You CAN'T join if...

  • Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
  • History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
  • At risk of suicide in the opinion of the investigator
  • Presence of significant cerebral vascular pathology as assessed by MRI central reader
  • Unstable or clinically significant cardiovascular, kidney or liver disease (e.g.,myocardial infarction)
  • Uncontrolled hypertension
  • Screening hemoglobin A1c (HbA1C)>8%
  • Poor peripheral venous access
  • History of cancer except:

    If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy

  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins

Locations

  • Stanford Univ Medical Center accepting new patients
    Palo Alto, California, 94304, USA
  • University of California, Davis; Alzheimers Disease Center, Department of Neurology accepting new patients
    Sacramento, California, 95817, USA
  • North Bay Neuro Science Institute accepting new patients
    Sebastopol, California, 95472, USA
  • American Neuropsychiatric Research Institute Inc terminated
    Carson, California, 90746, USA
  • Pharmacology Research Inst accepting new patients
    Encino, California, 91316, USA
  • Alliance for Wellness, dba Alliance for Research accepting new patients
    Long Beach, California, 90807, USA
  • Pharmacology Research Institute accepting new patients
    Los Alamitos, California, 90720, USA
  • UCLA Medical Center, Department of Neurology in progress, not accepting new patients
    Los Angeles, California, 90025, USA
  • USC Keck School Of Medicine accepting new patients
    Los Angeles, California, 90033, USA
  • Pharmacology Research Inst accepting new patients
    Newport Beach, California, 92660, USA
  • Shankle Clinic accepting new patients
    Newport Beach, California, 92663, USA
  • Anderson Clinical Research, Inc. accepting new patients
    Redlands, California, 92374, USA
  • Neurological Research Inst accepting new patients
    Santa Monica, California, 90025, USA
  • Collaborative Neuroscience Network Inc. accepting new patients
    Torrance, California, 90502, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02670083
Phase
Phase 3
Study Type
Interventional
Last Updated
April 2017