Good Rate of Clinical Response to Cholinesterase Inhibitors in 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.

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Key information

Conditions

Late Onset Alzheimer Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

59 year–93 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Acronym: NINDS-AIREN

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2013
First posted: Dec 10, 2013
Registry last updated: Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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