PRIME - NCT01677572Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease
Please note, some trial-specific information on this page is sourced from clinicaltrials.gov.
About
Trial summary
TYPEINTERVENTIONAL
PHASE
Phase
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PHASE1
CONDITION
Alzheimer's Disease
INTERVENTIONS
Interventions
The drug, device, or procedure being tested.
DRUG:Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)
Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study is conducted with a staggered, parallel group design, with the first 3 treatment arms conducted in parallel, 2 further treatment arms subsequently beginning in parallel and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
DRUG:Placebo
Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
ENROLLMENT
Enrollment
The number of participants needed to take part in this trial.
197 participants
(ACTUAL)
50 Years to 90 Years
(ADULT, OLDER ADULT)
LOCATIONS32
Key dates
Key dates
When the trial is conducted - from the date the first participant is enrolled to the date of the last participants's final visit.
Results from this trial have been made available. Some information may be redacted (edited) to protect privacy, publication rights, and confidential commercial information. To review the information please visit biogentrialtransparency.com.
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Please contact a clinical trial site directly to learn more about the trial. If no contact details are available, or for general inquiries, please contact the Biogen Clinical Trial Center.
