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Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment (NINDS-AIREN)

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Federal University of Minas Gerais

Status

Completed

Conditions

Late Onset Alzheimer

Study type

Observational

Funder types

Other

Identifiers

NCT02007291
0172 / 2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

All

Ages

59 to 93 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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