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

Purpose of the Study

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of BIIB080 in participants with Mild Cognitive Impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease dementia. The study will determine if BIIB080 can slow the worsening of AD more than placebo and on what dose of BIIB080 slows worsening of AD the most.

What to Expect

Over the course of study participation (2 years), you will:

• Be randomly assigned to a study group: BIIB080 (study drug) or placebo (saline solution, containing no active drug product). You do not get to pick your study group. You and your study doctor will not know if you are on the study drug or placebo.
• Come into the UCSF clinic for 18 study visits and participate in 15 follow-up phone calls.
• Have a spinal injection of the study drug or placebo once every 12 weeks for 76 weeks. You will also be asked to return to the study site approximately 6 weeks after each injection for safety follow up and research procedures.
• Undergo brain scans (MRI and PET), physical and neurological examinations, vital signs collection, blood and urine tests, lumbar punctures, and electrocardiograms (ECG).
• Complete questionnaires and undergo tests of your memory and daily functioning.