Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment (NINDS-AIREN)
Life expectancy in Brazil has increased markedly over the last 30 years. Hence, age-related disorders, such as Alzheimer's disease (AD), warrant special attention due to their high prevalence in the elderly. Pharmacologic treatment of AD is based on cholinesterase inhibitors (ChEI) and memantine, leading to modest clinical benefits both in the short and long-term.
However, clinical response is heterogeneous and needs further investigation. Objective: To investigate the rate of response to ChEI in AD after three months of treatment. Methods: Patients with mild or moderate dementia due to probable AD or to AD associated with cerebrovascular disease were included in the study.
Late Onset Alzheimer
|Study Design:||Time Perspective: Prospective|
|Official Title:||Good Rate of Clinical Response to Cholinesterase Inhibitors in Mild and Moderate Alzheimer's Disease After Three Months of Treatment|
- MMSE scores at three, six and twelve months indicate response to ChEI in mild and moderate Alzheimer's disease [ Time Frame: three, six and twelve months ] [ Designated as safety issue: No ]Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in AD. Clinical evaluations were performed at baseline and after three months. The domains examined and the evaluation tools were: cognition (Mini-Mental State Examination- MMSE+ Mattis Dementia Rating Scale- DRS), function (Katz - Basic Activities of Daily Living, and instrumental activities of daily living - Pfeffer Functional Activities Questionnaire - PFAQ), neuropsychiatric symptoms (Neuropsychiatric Inventory - NPI) and mood (Cornell Scale for Depression in Dementia - CSDD).
- Good rate of cognitive response to cholinesterase inhibitors after 3 months of treatment [ Time Frame: three, six and twelve months ] [ Designated as safety issue: No ]All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after three months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in Alzheimer's disease. The rate of good clinical response was determined based on the proportion of patients who gained 2 or more points on the MMSE after three months of treatment in relation to baseline. Neutral response was defined by variations between -1 and +1 on the MMSE score as compared to baseline, while bad response corresponded to a decrease of 2 or more points on the MMSE after three months.
Biospecimen Retention: Samples With DNA
A blood sample was drawn from the patients on the first consultation for use in DNA extraction and Apolipoprotein E (APOE) genotyping. For the patients who were taking donepezil, after three, six and twelve months of treatment another blood sample were also drawn, separated in plasma and kept into the freezer at - 70 Celsius degree for further analysis of serum level of donepezil.
|Study Start Date:||June 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
The subjects were assessed at baseline and again after three months of ChEI treatment. Subjects were submitted to the Mini-Mental State Examination (MMSE), Mattis Dementia Rating Scale, Katz Basic Activities of Daily Living, Pfeffer Functional Activities Questionnaire, Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia. Good response was defined by a gain of ≥2 points on the MMSE after three months of treatment in relation to baseline.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02007291
|Study Chair:||Paulo Caramelli, MD, PhD||Federal University of Minas Gerais|