- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007291
Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment (NINDS-AIREN)
Good Rate of Clinical Response to Cholinesterase Inhibitors in Mild and Moderate Alzheimer's Disease After Three Months of Treatment
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
A longitudinal, naturalist study, conducted at the Geriatric Outpatient Clinic of the Hospital das Clínicas at the Federal University of Minas Gerais (UFMG), in Belo Horizonte (MG), Brazil.
The sample comprised patients evaluated from June, 2009 until October, 2011.
Description
Inclusion Criteria:
- Patients fulfilling the National Institute on Aging and the Alzheimer's Association diagnostic criteria of probable AD dementia or the NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences) diagnostic criteria of AD with cerebrovascular disease (AD + CVD)
- Patients presenting mild or moderate dementia according to the Clinical Dementia Rating (CDR), i.e., CDR 1 or 2, respectively
Exclusion Criteria:
- Patients treated with ChEI or memantine before study entry
- Patients diagnosed with frontotemporal dementia, dementia with Lewy bodies or vascular dementia,
- Patients with CDR 3
- Illiterate patients
- Patients with different comorbidities, with signs of clinical decompensation
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease
Time Frame: three months
|
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 Alzheimer's Disease.
The main domain examined and the evaluation tools was cognition and Mini-Mental State Examination- MMSE, respectively.
MMSE scores range from 0 to 30, while the greater value is associated with a better cognition state.
An increase of 2 or more points in MMSE was considered as response.
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease
Time Frame: three months
|
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.
The secondary domain examined was independence for daily activities and the evaluation tools used was the brazilian version of the Pfeffer Functional Activities Questionnaire (PFAQ).
PFAQ scale range from 0 to 30 points and the greater value is associated with a greater dependence in daily activities.
|
three months
|
Collaborators and Investigators
Investigators
- Study Chair: Paulo Caramelli, MD, PhD, Federal University of Minas Gerais
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0172 / 2010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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