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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Paulo Caramelli, MD, PhD | Federal University of Minas Gerais | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | CDR1 Patients Taking Cholinesterase Inhibitors | The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription. |
| FG001 | CDR2 Patients Taking Cholinesterase Inhibitors | The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Taking Cholinesterase Inhibitors | The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | 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. | Posted | Mean | Standard Deviation | units on a scale | three months |
|
3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDR1 Patients Taking Cholinesterase Inhibitors | The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luís Felipe José Ravic de Miranda | Federal University of Minas Gerais | 55-31-3225-2337 | ravicmiranda@gmail.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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A blood sample was drawn from the patients on the first consultation for use in DNA extraction and Apolipoprotein E (APOE) genotyping. For the patients who were taking donepezil, after three, six and twelve months of treatment another blood sample were also drawn, separated in plasma and kept into the freezer at - 70 Celsius degree for further analysis of serum level of donepezil.
| three months |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription. |
| OG001 | CDR 2 Patients Taking Cholinesterase Inhibitors | The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription. |
|
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| Secondary | Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | 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. | Posted | Mean | Standard Deviation | units on a scale | three months |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | CDR2 Patients Taking Cholinesterase Inhibitors | The sample comprised patients evaluated from June, 2009 until October, 2011.During this period, 71 patients were evaluated at baseline and after 3 month-treatment. Donepezil, rivastigmine or galantamine were prescribed to the patients according to the clinicians' preferences. The target dosages considered for treatment effect evaluation were 5 to 10 mg for donepezil, 16 to 24 mg for galantamine and 6 to 12 mg for rivastigmine. The first investigator (LFJRM) did not have any influence on the prescription. | 0 | 23 | 0 | 23 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |