A Phase III study of the drug aducanumab
The Biogen study is a clinical research study for older individuals with early Alzheimer’s disease (AD), including mild cognitive impairment (MCI).
Aducanumab is a human antibody that recognizes some forms of beta-amyloid. The primary objective of the study is to evaluate the efficacy of aducanumab in slowing cognitive and functional impairment. This drug is not FDA-approved and is investigational.
Participants are randomly assigned to receive a low or high dose of the investigational study drug or placebo (non-active agent used for comparison). The drug or the placebo is given by an intravenous infusion.
After an 18-month placebo-controlled period, participants may enter a 24-month study during which all participants will be given aducanumab.
Who may be eligible to participate?
Individuals 50-85 years of age with a diagnosis of early Alzheimer’s disease (AD), including mild cognitive impairment (MCI).
Participants must have a reliable study partner: a spouse, relative, or friend who knows the participant well and see him or her often, who will attend some study visits, and who will provide information about the participant during the study.
A screening visit (parts of which may be spaced out over two or three non-continguous days) will determine eligibility. It includes:
- a physical/neurological exam
- medical history
- medication review
- electrocardiogram (ECG)
- collection of blood and urine
- tests of memory and thinking
- brain MRI/PET scan
After the screening, study activity includes:
- One “baseline” visit, then 19 infusions spaced out every 4 weeks at the Clinical Translational Research Center at the Hospital of the University of Pennsylvania.
- After 18 months, participants may enter a 24-month study during which all participants will receive 26 monthly infusions of aducanumab over 24 months.
- An optional substudy will include a lumbar puncture (LP) or “spinal tap”
Participants will be reimbursed for time and travel.
Before enrolling, the participant and study partner must read, understand, and sign a formal consent form, which fully explains the study.
For more information, contact Study Coordinator Grace Stockbower at 215-746-3949 or firstname.lastname@example.org.