Alzheimer's Disease
Conditions
Interventions
infusion through a vein once a month (every 4 weeks) for about 2 years. 
In the core treatment period, the subject will receive the study drug as an 
Subjects will receive 26 infusions and each infusion will last about 1 hour. 
During the LTE Treatment Period subjects will receive the study drugs for 
another 52 weeks (an additional 13 doses).
As this is an open-label study the subject and the investigator will know which 
dose you are receiving. Subjects will receive the study drug Aducanumab at 
increasing doses as follows:
o Infusions 1 and 2 (Weeks 1 and 4): 1 mg/kg
o Infusions 3 and 4 (Weeks 8 and 12): 3 mg/kg
o Infusions 5 and 6 (Weeks 16 and 20): 6 mg/kg
o Infusions 7 to 39 (once every 4
Sponsors
IQVIA RDS Netherlands B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Core treatment period - Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (Studies 221AD301, 221AD302, 221AD103 and 221AD205, referred to as "feeder studies"). - Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. LTE Treatment Period: - Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator. - Has one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. Other protocol defined Inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: Core treatment period - Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment. -Stroke or any unexplained loss of consciousness within 1 year prior to Screening. -Clinically significant unstable psychiatric illness in past 6 months. -History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening. - A seizure event that occurred after the last visit of the feeder study and before Screening for this study. - Evidence of impaired liver function as shown by an abnormal liver function profile at Screening. - History of or known seropositivity for HIV. - Clinically significant systemic illness or serious infection within 30 days prior to or during Screening. - Contraindications to having a brain magnetic resonance imaging (MRI). LTE Treatment Period: - Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study. Other protocol defined Exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint Incidence of AEs, SAEs, ARIA, and immunogenicity over 100 weeks of treatment and/or re-exposure to aducanumab. Safety and tolerability parameters include the following: • Incidence of all AEs, AEs leading to treatment discontinuation or study withdrawal, and all SAEs • Incidence of ARIA-E and ARIA-H • Incidence of ADAs in serum | — |
Secondary
| Measure | Time frame |
|---|---|
| Core Exploratory endpoints: 1. Changes in cognition, neuropsychiatric status, function, and quality of life as measured by: - CDR-SB score - ADAS-Cog 13 score - ADCS-ADL-MCI score - MMSE score - MOCA score - NPI-10 total score - Health Economics and Outcome Research measures of EQ-5D (SR); EQ-5D (IR-S); EQ-5D (IR-I); mPDQ-20; CAM; and ADCS-MCI-CGIC 2. - PET Imaging (optional substudy): Change in: Tau PET signal (in a subset of sites and participants) - MRI Imaging: Change in MRI morphometric measures of regional brain volume - Fluid biomarkers (blood and optional CSF): Change in levels of fluid biomarkers related to disease which may include, but are not limited to tau proteins (in a subset of participants). 3. Minimum concentration prior to administration of the dose every 6 months LTE exploratory endpoints: 1. Incidence of AEs, SAEs, ARIA, and immunogenicity with long-term treatment of aducanumab. Safety and tolerability parameters include the following: • Incidence of all AEs, AEs leading to treatment discontinuation or study withdrawal, and all SAEs • Incidence of ARIA-E and ARIA-H • Incidence of ADAs in serum 2. Changes in cognition, neuropsychiatric status, function, and quality of life as measured by the following: • CDR-SB score • ADAS-Cog 13 score • ADCS-ADL-MCI score • MMSE score • MOCA score • NPI-10 total score • RUD • Zarit Burden 3. • PET Imaging (substudy): Change in Amyloid PET signal (in a subset of sites and participants) • PET Imaging (substudy): Change in Tau PET signal (in a subset of sites and participants) •Fluid biomarkers (blood and optional CSF): Change in levels of fluid biomarkers related to disease which may include, but are not limited to, amyloid and tau proteins (in a subset of participants) 4. Minimum concentration prior to administration of the dose every 6 months | — |
Countries
Netherlands
Outcome results
None listed