Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment

NCT ID: NCT02007291

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-03-31

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.

Conditions

Late Onset Alzheimer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 59 Years
• Maximum Eligible Age: 93 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Luís Felipe José Ravic de Miranda

Physician, Geriatrician, MD, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo Caramelli, MD, PhD

Role: STUDY_CHAIR

Federal University of Minas Gerais

Other Identifiers

0172 / 2010

Identifier Type: -

Identifier Source: org_study_id