A Phase 1 Clinical Research Study for People with Mild Alzheimer’s Disease
You are invited to participate in a research study looking at a new drug which may be used to treat people who have been diagnosed with Alzheimer’s disease. The purpose of this study is to evaluate the safety and tolerability of BIIB076, and to measure how it moves through and is eliminated by the body. The study drug, BIIB076 is an investigational drug. An investigational drug is one that is not approved for marketing by the U.S. Food and Drug Administration (FDA).
This is the first time that BIIB076 is being given to humans.
The study is being conducted by Dr. Farlow, and Indiana University / Department of Neurology. Study visits take place at University Hospital in Indianapolis and Goodman Hall at IU Health Neuroscience Center in Indianapolis. It is funded by the study sponsor, Biogen. Biogen makes the study drug being evaluated in this study.
The study duration is approximately 20 weeks, not including the screening period. This study requires one stay of 4 or 5 days and 3 or 4 nights followed by approximately 9 further study visits lasting 2-6 hours. The research unit may arrange for you to stay a fourth night prior to the first of these outpatient visits. A screening visit is required to determine if you qualify and are willing to participate in this study.
You will be randomly (by chance) assigned to receive either study drug (BIIB076) or placebo. Placebo is an inactive substance containing no study drug. You have a 75 percent chance of receiving the active study drug. A single dose of BIIB076 or placebo will be administered on Day 1 and no additional doses will be given. The study can be stopped at any time, based on the effects of the study drug or other reasons.
Screen Visit:Review informed consent form, physical and neurological exam, blood and urine tests, *ECG, **Brain MRI, ***lumbar puncture (LP), medical and medication history review, mini-mental rating assessment (MMSE)
Hospital Visit: Admission to the research unit, blood and urine tests, ECGs, physical and neurological exams, medical and medication reviews, vital signs, and safety monitoring. Single dose of study drug, or placebo via infusion lasting approximately 2 hours occurs on Day 1.
Outpatient Visits: Physical and neurological exams, ECGs, vital signs, blood tests, safety monitoring, medication reviews, 2 additional lumbar punctures, and 2 additional brain MRIs
*ECG = Electrocardiogram (displays electrical activity of your heart)
**MRI = Magnetic Resonance Imaging (uses magnetic field and pulses of radio wave energy to make images)
***LP = Lumbar Puncture (used to evaluate cerebrospinal fluid)
A lumbar puncture (LP) is also commonly called a spinal tap. This involves placing a needle in the lower back to obtain a sample of fluid that bathes the brain and spinal cord (this fluid is called cerebrospinal fluid or CSF). The needle enters a sac below the actual spinal cord. The lower back is generally considered the safest site to obtain this fluid for laboratory testing.
Blood samples will be taken approximately 22 times throughout the course of the study. For blood collections that occur during the overnight stay, an intravenous catheter (a small flexible tube) may be inserted temporarily into a vein (by a needle) in your arm and kept open in order to collect blood samples and avoid multiple punctures.
Must be 50-80 years old
Must have a clinical diagnosis of mild Alzheimer's Disease (AD)
Must have a reliable caregiver/study partner who is in frequent contact with the participant (at least 10 hours per week) and will accompany the participant to the office and/or be available by telephone at designated times.
Must be willing and able to have a brain MRI scan
Must be willing and able to have a lumbar puncture (LP)
Must be willing to abstain from tobacco-containing products for 72 hours prior to the study and during the monitoring period.
Females of childbearing potential and all male subjects must practice highly effective contraception during the study and be willing and able to continue contraception for 6 months after the dose of study treatment.
You will not be responsible for the costs related to participating in this study. Biogen pays for all study costs. However, you are responsible for any transportation and/or living costs incurred while traveling to and from the research unit.
You will receive payment for taking part in this study. Total compensation for study completion will be up to $2600.00. The payment will be in a form of a pre-paid Visa debit card. Payments will be loaded on the card and it is important that you do not throw away or lose the Visa debit card. If you choose to withdraw or are withdrawn from the research study, you will receive compensation only for the portion of the study that you have completed. Parking will be provided.
- IRB Number: 1706911662
- Research Study Identifier: TX7969
- Principal Investigator: Martin Farlow, MD