Late Onset Alzheimer
Conditions
Keywords
Alzheimer, MMSE, response, colinesterase inhibitors (ChEI)
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.
Interventions
None listed
Sponsors
Federal University of Minas Gerais
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
59 Years to 93 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | 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
| Measure | Time frame | Description |
|---|---|---|
| Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | Patients Taking Cholinesterase Inhibitors |
|---|---|
| Age, Customized ≤ 69 years old | 12 Participants |
| Age, Customized 70-79 years old | 36 Participants |
| Age, Customized ≥ 80 years old | 23 Participants |
| Region of Enrollment Brazil | 71 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 23 |
| serious Total, serious adverse events | 0 / 48 | 0 / 23 |
Outcome results
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.
Time frame: three months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CDR 1 Patients Taking Cholinesterase Inhibitors | Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | MMSE- baseline | 19 units on a scale | Standard Deviation 4.3 |
| CDR 1 Patients Taking Cholinesterase Inhibitors | Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | MMSE - 3 months | 18.9 units on a scale | Standard Deviation 4.5 |
| CDR 2 Patients Taking Cholinesterase Inhibitors | Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | MMSE- baseline | 11.3 units on a scale | Standard Deviation 2.4 |
| CDR 2 Patients Taking Cholinesterase Inhibitors | Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | MMSE - 3 months | 11.5 units on a scale | Standard Deviation 2.8 |
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.
Time frame: three months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CDR 1 Patients Taking Cholinesterase Inhibitors | Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | PFAQ - baseline | 14.9 units on a scale | Standard Deviation 8.8 |
| CDR 1 Patients Taking Cholinesterase Inhibitors | Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | PFAQ - 3 months | 16.2 units on a scale | Standard Deviation 8.8 |
| CDR 2 Patients Taking Cholinesterase Inhibitors | Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | PFAQ - baseline | 26.9 units on a scale | Standard Deviation 4.1 |
| CDR 2 Patients Taking Cholinesterase Inhibitors | Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease | PFAQ - 3 months | 27.1 units on a scale | Standard Deviation 3.5 |