A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

Alzheimer's Disease Clinical Trial

— EVOLVE  

Official title:

A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects With Asymptomatic Amyloid-Related Imaging Abnormalities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03639987
• Other study ID #: 221AD205
• Secondary ID: 2018-002102-31
• Status: Terminated
• Phase: Phase 2
• Start date: December 20, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD dementia. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion/ Exclusion Criteria

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 NIA-AA 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)), or Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive)).

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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Dementia

Intervention

Drug:
• Aducanumab
Administered as specified in the treatment arm.
• Placebo
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
United States	JEM Research Institute	Atlantis	Florida
United States	Senior Adult Specialty Research	Austin	Texas
United States	Medical Research Health and Education Foundation, Inc	Columbus	Georgia
United States	Neurology Clinic, PC	Cordova	Tennessee
United States	Brain Matters Research	Delray Beach	Florida
United States	Neuropsychiatric Research Center of Southwest Florida	Fort Myers	Florida
United States	Neurology Center of North Orange County	Fullerton	California
United States	Baylor College Of Medicine	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Josephson, Wallack, Munshower Neurology, P.C.	Indianapolis	Indiana
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Bioclinica Orlando	Orlando	Florida
United States	Pacific Neuroscience Medical Group	Oxnard	California
United States	Banner Alzheimer's Institute	Phoenix	Arizona
United States	National Clinical Research Inc.-Richmond	Richmond	Virginia
United States	Pacific Research Network, Inc	San Diego	California
United States	California Neuroscience Research Medical Group Inc.	Sherman Oaks	California
United States	Kingfisher Cooperative, LLC	Spokane	Washington
United States	Bioclinica Orlando	The Villages	Florida
United States	Advanced Memory Research Institute of NJ, PC	Toms River	New Jersey
United States	Center for Neurosciences	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)		up to Week 54
Secondary	Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)	ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).	up to Week 54
Secondary	Time to Onset of ARIA as Obtained on MRI		up to Week 54
Secondary	Time to Resolution of ARIA as Obtained on MRI		up to Week 54
Secondary	Number of Participants With Symptomatic ARIA by Severity	ARIA by severity was obtained on Magnetic Resonance Imaging (MRI).	up to Week 54
Secondary	Time to Onset of Symptomatic ARIA		up to Week 54
Secondary	Time to Resolution of Symptomatic ARIA		up to Week 54
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death, in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event), however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.	up to Week 54
Secondary	Change From Baseline in the Montreal Cognitive Assessment (MoCA) at Week 54		Baseline, Week 54
Secondary	Number of Participants With Aducanumab Concentration in Serum		up to Week 54
Secondary	Number of Participants With Antiaducanumab Antibodies in Serum		up to Week 54