Clinical trial NCT05097131: An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the US
Official title: International Collaboration for Real-World Evidence in Alzheimer's Disease (ICARE AD)- A Prospective Real-World Observational Study of Aducanumab-avwa in Patients With Alzheimer's Disease in the US
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimers Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who have been prescribed with aducanumab-avwa in the post-marketing setting according to standard care of practice.

Brief summary: This is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the US. Investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (SoC). Participants will be followed up to 5 years after enrollment and data will be collected at routine visits every 6 to 12 months.


Eligibility criteria: Key Inclusion Criteria:

* Participant has a diagnosis of Alzheimer's Disease (AD) and is prescribed aducanumab-avwa by their treating physician.
* Participant's treating physician has made the decision to initiate aducanumab-avwa prior to participant inclusion and independently of the purpose of the study.

Key Exclusion Criteria:

* Participant concurrently participates in any interventional clinical study.
* Participant has ever been treated with aducanumab-avwa at a dose of 3 milligrams per kilogram (mg/kg) or greater prior to signing ICF.
* Participant has ever been treated with aducanumab-avwa and discontinued treatment prior to signing ICF.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Change from Baseline in Quick Dementia Rating Scale Informant Version & Patient Version (QDRS-IV/PV) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADL-Q-SV) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Functional Activities Questionnaire (FAQ) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Montreal Cognitive Assessment Version 8.1 (MoCA v8.1) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
timeFrame: Baseline up to 5 years
measure: Change from Baseline in Geriatric Depression Scale Short Form (GDS-SF) Score
timeFrame: Up to 5 years
measure: Change from Baseline in 13-Item Quality of Life in Alzheimer's Disease (QoL-AD) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Zarit Burden Interview (22-Item) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Short Form 12 Version 2 (SF-12v2) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Health Care Resource Utilization (HCRU) Using Resource Utilization in Dementia Lite (RUD Lite)
timeFrame: Up to 5 years
measure: Change form Baseline in Patient Global Impressions Scale of Severity (PGI-S) Score
timeFrame: Up to 5 years
measure: Change from Baseline in Patient Global Impression of Change (PGI -C) Score
timeFrame: Up to 5 years
Secondary outcomes:
measure: The Number of Participants With Adverse Events (AEs), Including Amyloid-Related Imaging Abnormality (ARIA), andSerious Adverse Events (SAEs) in Aducanumab-avwa-treated Participants in Real-world Per Label Recommendation
timeFrame: Up to 5 years
measure: To Obtain Descriptive Statistics on the Characteristics of the Aducanumab-avwa User Population and on Drug Utilization
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Valencia
country: United States
facility: Mehdi Meratee MD
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health System, Inc
state: Florida
city: Palmetto Bay
country: United States
facility: Imic, Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies, Inc
state: Florida
city: Vero Beach
country: United States
facility: Vero Beach Neurology and Research Institute
state: Florida
city: Chicago
country: United States
facility: Northwest Neurology
state: Illinois
city: Ozark
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Patchogue
country: United States
facility: South Shore Neurologic Associates, P.A.
state: New York
city: Asheboro
country: United States
facility: Carolina Clinical Research & Consulting, LLC
state: North Carolina
city: Matthews
country: United States
facility: Research Site
state: North Carolina
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Centerville
country: United States
facility: Dayton Center for Neurological Associates
state: Ohio
city: Portland
country: United States
facility: Center for Cognitive Health
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Port Royal
country: United States
facility: Coastal Neurology, PA
state: South Carolina
city: Knoxville
country: United States
facility: Genesis Neuroscience Clinic
state: Tennessee
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: