A Study of Aducanumab in Participants With MildCognitive Impairment due to Alzheimer’s Disease orWith Mild Alzheimer’s Disease Dementia to Evaluate theSafety of Continued Dosing in Participants WithAsymptomatic Amyloid-Related Imaging Abnormalities
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Mild Cognitive Impairment due to Alzheimer's Disease and Mild Alzheimer's DementiaMedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852
- Registration Number
- EUCTR2018-002102-31-IT
- Lead Sponsor
- BIOGEN IDEC RESEARCH LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 500
Key Inclusion Criteria:
• Ability of the participant or his/her legally authorized representative to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential
health information in accordance with national and local
participant privacy regulations.
• Must have at least 6 years of education or work
experience to exclude mental deficits other than MCI
due to AD or mild AD dementia.
• Must have evidence of cerebral Aß accumulation, based on a positive PET scan of the brain. Previously obtained positron emission tomography (PET) scan
(within 12 months of screening) is permissible. Previous PET scan images must be submitted to the central imaging vendor to confirm that study inclusion criteria
are met.
• Must consent to apolipoprotein E (ApoE) genotyping.
• Must meet all of the following clinical criteria for MCI due to AD or mild AD dementia according to NIAAA criteria [Albert 2011; McKhann 2011], and must have
the following: MCI due to AD (a CDR global score of 0.5, and an MMSE score between 24 and 30
(inclusive)), and Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive)).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
Key Exclusion Criteria:
• Any uncontrolled medical or
neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the participant’s cognitive
impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia,
frontotemporal dementia, head trauma).
• Clinically significant unstable psychiatric illness
(e.g., uncontrolled major depression, uncontrolled
schizophrenia, uncontrolled bipolar affective disorder)
within 6 months prior to Screening.
• Transient ischemic attack or stroke or any
unexplained loss of consciousness within 1 year prior to Screening.
• Vaccinations within 10 days prior to randomization (Day 1).
• Female participants who are pregnant or currently breastfeeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in<br>asymptomatic Amyloid-related Imaging Abnormalities<br>(ARIA) in participants with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or with mild AD dementia.;Secondary Objective: The secondary objective of the study is to characterize ARIA, from both the imaging and the clinical perspective and to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of aducanumab.;Primary end point(s): Primary endpoint:<br>Number of Clinically Impactful<br>Amyloid-related Imaging<br>Abnormalities (ARIA)<br><br>Clinically impactful ARIA is<br>defined as symptoms and/or<br>signs associated with ARIA<br>that are life threatening,<br>require hospitalization, and/or<br>result in persistent or<br>significant disability as<br>assessed by the independent<br>Adjudication Committee.;Timepoint(s) of evaluation of this end point: Primary endpoint:<br>Baseline up to Week 54
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Number of Participants With<br>ARIA by Severity as Obtained<br>on Magnetic Resonance<br>Imaging (MRI)<br>2. Time to Onset of ARIA as<br>Obtained on MRI<br>3. Time to Resolution of ARIA as<br>Obtained on MRI<br>4. Number of Participants With<br>Symptomatic ARIA by Severity<br>5. Time to Onset of Symptomatic<br>ARIA<br>6. Time to Resolution of<br>Symptomatic ARIA<br>7. Number of Participants With<br>Adverse Events (AEs) and Serious Adverse Events (SAEs)<br>8.Change From Baseline in the<br>Montreal Cognitive<br>Assessment (MoCA) at Week<br>54<br>9.Aducanumab Concentration in<br>Serum<br>10. Number of Participants With<br>Antiaducanumab Antibodies in<br>Serum;Timepoint(s) of evaluation of this end point: Secondary endpoints ;<br> 1-7 will be Baseline up to week 54.<br><br>Secondary endpoint 8 ; baseline, week 54 <br>Secondary endpoint 9 and 10; Pre-dose on Day 1 of<br>Weeks 1, 16, 24, 32, 44,<br>54, 56, 70, 80, 104<br>