Alzheimer's Disease MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: - The participant must have confirmed amyloid beta pathology by CSF (historical CSF test results not allowed) or amyloid PET - The participant must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner - The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time - The participant must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to NIA-AA criteria [Albert 2011; McKhann 2011]: a. Have an MMSE score between 22 and 30 inclusive b. Have a CDR memory score >0.5 c. Have a CDR-GS of 0.5 or 1.0 d. Have a RBANS score of 85 or lower indicative of objective cognitive impairment (based upon the DMI score). - The participant must be in good health, apart from a clinical diagnosis of early Alzheimer's disease, as determined by the Investigator based on medical history and screening assessments - The participant must consent to ApoE genotyping - Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE e4 carriers) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 195 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1317
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: - Any uncontrolled medical or neurological/neurodegenerative condition (other than Alzheimer's disease) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment - Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening - Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening - History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product - Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available - Current use or previous use of medications with a purported disease modifying effect in Alzheimer's disease, outside of investigational studies - Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures - Use of any investigational drug - Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.) - A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the CDR-SB score as compared with placebo in participants with early Alzheimer's disease.;Secondary Objective: Key Secondary Objectives: To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by the iADRS. To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by ADCS-ADL-MCI. To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by ADASCog13. To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by the MMSE. To assess the effect of monthly doses of aducanumab as compared with placebo on clinical decline as measured by NPI- 10.;Primary end point(s): Change from baseline in CDR-SB score;Timepoint(s) of evaluation of this end point: Week 78 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in iADRS score 2. Change from baseline in ADCS-ADL-MCI score 3. Change from baseline in ADAS-Cog13 score 4. Change from baseline in MMSE score 5. Change from baseline in NPI-10 score 6. Change from baseline in PET Signal 7. Change from baseline in Tau PET Signal 8. Change from baseline in CDR-SB Score 9. Change from baseline in GST Composite Z-Score;Timepoint(s) of evaluation of this end point: 1. Week 78, Week 106 2. Week 78, Week 106 3. Week 78, Week 106 4. Week 78, Week 106 5. Week 78, Week 106 6. Week 78, Week 104 7. Week 78, Week 104 8. Week 106 9. Week 78, Week 106 | — |
Countries
Australia, Belgium, Brazil, Canada, China, Finland, Germany, Italy, Mexico, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactBiogen España
Biogen Idec Research Limited
Outcome results
None listed