Clinical Trials Watch
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Name of the study
221AD301 A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease
Information about the drug that will be tested in the study
Name of drug
The drug will be administered via an intravenous infusion (an injection into the vein) once every four weeks. The infusion lasts around 60 minutes.
Is the drug already on the market for another medical condition?
Will all participants receive the same drug?
Participants will be selected at random to either receive one of the following options:
- Low dose of aducanumab via an intravenous infusion (an injection into the vein)
- High dose of aducanumab via an intravenous infusion (an injection into the vein)
- An intravenous infusion of placebo (a dummy treatment).
Participants will have a two-in-three chance of receiving aducanumab, and a one-in-three chance of receiving a placebo.
Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The researchers aim to evaluate the safety and efficacy of aducanumab (the investigational drug) in slowing cognitive and functional impairment in people with mild Alzheimer’s disease.
How long will the treatment last?
The study will last one and a half years.
Participants will receive the infusion every 4 weeks.
After the completion of the study, eligible participants (including those in the placebo group) will be offered the opportunity to participate in an extension study where all the participants will receive aducanumab.
What will your involvement entail?
During the study, participants (and/or their caregivers) will be asked to complete different tests that will assess their cognition, functioning, behaviour, quality of life and the level of burden of their caregiver.
In addition, during the study participants will be asked to undertake different brain scans (i.e. MRI - magnetic resonance imaging and PET -positron emission tomography).
Optional assessments are: spinal tap (lumbar puncture, to check markers in their cerebrospinal fluid) and additional brain scan (PET).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, the person must:
- Be between 50 and 85 years old.
- Have a brain scan (PET) that indicates that the person has abnormal deposits of amyloid in the brain (these deposits are considered hallmarks of Alzheimer's disease).
- Participants are not expected to have had a brain scan (PET) prior to expressing their interest in this study. The doctors of the study will perform a series of clinical assessments to determine if the person can take part in the study. If individuals meet the clinical criteria, brain scans (PET) will be provided to potential participants at the end of the screening process.
- Meet clinical criteria (according to the National Institute on Aging- Alzheimer’s Association) for either:
- Mild Cognitive Impairment due to Alzheimer’s disease (i.e. mild changes in memory and thinking abilities that are noticeable to the person and others and that can be measured, but that do not affect the person’s ability to carry out everyday activities, and presence of certain biomarkers – such as amyloid or tau protein – in the brain)
- Mild Alzheimer’s disease.
- Be willing to complete different tests assessing his/her cognition (e.g. CDR, MMSE, RBANS) and his/her scores should suggest that he/she has a cognitive impairment that is very mild.
- Consent to undergo a genetic test (ApoE genotyping).
- Have a reliable informant or caregiver.
If taking any of the approved drugs for Alzheimer’s disease (i.e. donepezil, rivastigmine, galantamine or memantine), doses must be stable for at least eight weeks prior to the screening visit. Participants will not be allowed to change treatment or dosage during their participation in the study.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Any medical or neurological condition (other than Alzheimer's disease) that might be a contributing cause of the cognitive impairment.
- A stroke or a mini-stroke (Transient Ischemic Attack - TIA) or unexplained loss of consciousness in the past year.
- A clinically significant psychiatric illness in past 6 months.
- Unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to screening visit.
- Impaired renal (kidneys) or liver function.
- Human immunodeficiency virus (HIV) infection.
- A significant systemic illness or infection in past 30 days (e.g. a condition or infection affecting the whole body or an entire system, as opposed to a single organ or body part)
- Relevant brain haemorrhage, bleeding disorder and cerebrovascular abnormalities.
- Alcohol or substance abuse in past 1 year
- Have any contraindication to brain scans (MRI or PET scans).
- Be taking blood thinners (except for aspirin at a prophylactic dose or less
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Where and when will the study be conducted?
European countries involved in the trial
- United Kingdom
Estimated start date of recruitment
Information for your doctor
Study contact information
Link to full text
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website)
The pharmaceutical company running this trial (BIOGEN) has reviewed this document.
This document has been reviewed by a member of the European Working Group of People with Dementia.
Last Updated: Wednesday 13 July 2016