Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02670083 : CREAD Study: A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)
PhasePhase 3
AgesMin: 50 Years Max: 85 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02670083      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2018 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740