ALZHEIMER’S OBSERVATIONAL INTERNATIONAL STUDY
Research type
Research Study
Full title
PROSPECTIVE NON-INTERVENTIONAL STUDY OF PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE AND THEIR CAREGIVERS IN FOUR EUROPEAN COUNTRIES
IRAS ID
209226
Contact name
Ira Leroi
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Clinicaltrials.gov Identifier
DEME 30373, NIHR number
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The prevalence of Alzheimer’s disease (AD) results in an increasingly large burden to society that rises in direct proportion to the number of elderly persons in the population.
Earlier identification, prevalence of related disorders or diseases, and treatments may affect AD trajectory and outcomes, including resource utilization and costs.
Prospective observational studies are needed to assess the course of disease progression and the transition to major care modifications such as increased professional care and institutionalization in the current setting, reflecting the outcomes and associated costs of care of a patient population diagnosed, followed up and managed according to the current practice.
Observational, prospective longitudinal cohort study of patients with mild or moderate AD and their caregivers. Data will be collected at six-monthly intervals, during up to tow years. Assessment of change over time in patient’s cognitive and functional impairment and neuropsychological behavioral symptoms will be performed using a battery of clinical outcome assessment (COA) instruments. Other assessments include resource utilization, patient’s and caregiver’s quality of life (QoL) and caregiver’s subjective burden.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0566
Date of REC Opinion
19 Aug 2016
REC opinion
Favourable Opinion