CELIA
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia
IRAS ID
1006019
Contact name
Matthew Stagray
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2021-006036-13
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study. The purpose of this study is to look at whether the study drug BIIB080 can help people with Mild Cognitive Impairment due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia. The study is also to determine how safe the study drug is, and how the body handles taking it (known as tolerability).
The study is being carried out at about 140 sites in approximately 18 countries around the world. Across all sites, about 735 participants will take part in the study
Participation in the study will last for 105 weeks (about 2 years) in total. Participants will have up to 18 study site visits and up to 15 follow-up telephone calls. All participants must have a study partner who is available to accompany them to study site visits and provide information about the participant to the study doctor.
The study will have 3 periods:
• Screening period (about 9 weeks)
• Treatment period (76 weeks or approximately 18 months)
• Follow-up period (20 weeks or 5 months)
Eligible participants will be assigned randomly to 1 of 4 dosing groups to receive:
• Group 1: 60 mg of the study drug, every 24 weeks
• Group 2: 115 mg of the study drug, every 12 weeks
• Group 3: 115 mg of the study drug, every 24 weeks
• Group 4: a placebo, every 12 weeks.
A placebo looks like the study drug but contains no active medication. It is used to help determine if the results of the study are due to the study drug or due to something else.The investigational medication is given through an injection in the spine.
Biogen Idec Research Limited is the study sponsor.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0269
Date of REC Opinion
24 Oct 2022
REC opinion
Further Information Favourable Opinion