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CREAD Study: A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02670083
First received: January 28, 2016
Last updated: June 30, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Drug: Crenezumab Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change from baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, Week 105 ]

Secondary Outcome Measures:
  • Mean change from baseline to Week 105 in Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (subscale) 13 (ADAS-Cog-13) Score [ Time Frame: Baseline, Week 105 ]
  • Time to clinically evident decline (slowing functional and cognitive decline and disease progression), as determined by confirmed clinical decline on the MMSE scale and time to loss of activity of daily living (ADL) [ Time Frame: up to 105 weeks ]
  • Change from Baseline to Week 105 in CDR-GS [ Time Frame: Baseline, Week 105 ]
  • Mean change from baseline to Week 105 in ADAS-Cog (subscale) 12 (ADAS-Cog-12) score [ Time Frame: Baseline, Week 105 ]
  • Time to an increase of >=4 points from baseline at any time before or on Week 105 in the ADAS-Cog-13 [ Time Frame: up to Week 105 ]
  • Mean change from baseline to Week 105 in ADCS-ADL instrumental subscale score [ Time Frame: Baseline, Week 105 ]
  • Mean change from baseline to Week 105 in ADCS-ADL total score [ Time Frame: Baseline, Week 105 ]
  • Mean change from baseline to Week 105 in dependence level assessed from the ADCS-ADL score [ Time Frame: Baseline, Week 105 ]
  • Change from baseline to Week 105 in Neuropsychiatric Inventory (NPI) scores [ Time Frame: Baseline, Week 105 ]
  • Change from baseline to Week 105 in the Quality of Life-Alzheimer's Disease (QoL-AD) scale score [ Time Frame: Baseline, Week 105 ]
  • Change from baseline to Week 105 in the Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) scale score [ Time Frame: Baseline, Week 105 ]
  • Change from Baseline to Week 105 in EQ-5D questionnaire domain scores [ Time Frame: Baseline, Week 105 ]
  • Percentage of participants with adverse event and serious adverse event [ Time Frame: Up to Week 105 ]
  • Mean change from baseline to Week 105 in MMSE Score [ Time Frame: Baseline, Week 105 ]

Estimated Enrollment: 750
Actual Study Start Date: March 22, 2016
Estimated Study Completion Date: July 31, 2021
Estimated Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crenezumab
Participants will receive IV infusion of crenezumab q4w for 100 weeks.
Drug: Crenezumab
Crenezumab will be administered by IV infusion q4w for 100 weeks.
Placebo Comparator: Placebo
Participants will receive placebo q4w for 100 weeks.
Drug: Placebo
Placebo will be administered as IV infusion q4w for 100 weeks.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02670083

Contacts
Contact: Reference Study ID Number: BN29552 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 264 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02670083     History of Changes
Other Study ID Numbers: BN29552
Study First Received: January 28, 2016
Last Updated: June 30, 2017

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2017