Clinical trial NCT02007291: Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment
Official title: Good Rate of Clinical Response to Cholinesterase Inhibitors in Mild and Moderate Alzheimer's Disease After Three Months of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Late Onset Alzheimer
Keywords: Alzheimer, MMSE, response, colinesterase inhibitors (ChEI)
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 71
Sex: ALL
Minimum age (years): 59
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease
timeFrame: three months
Secondary outcomes:
measure: Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Minas Gerais
name: Paulo Caramelli, MD, PhD
role: STUDY_CHAIR
References: