Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets

Study Overview
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Brief Summary
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This study assessed the Hr QoL (Health related Quality of life) of subjects with mild to moderate AD, who received ARICEPT under usual clinical practice.

Detailed Description
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This non-interventional study enrolled patients with mild to moderate dementia of the Alzheimer's type, who have been prescribed treatment with ARICEPT under usual clinical practice.

Official Title
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Quality Of Life Assessment In AD Patients Receiving Aricept Tablets (Donepezil Hydrochloride)

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Alzheimer's Disease Exclusion Criteria: There are no exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AD patients<br> | Other: No intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse. | Baseline, Week 12. | 
| Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'. | Baseline, Week 12. | 
| Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. | Baseline, Week 12. | 
| Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. | Baseline, Week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study. | Baseline to Week 12. | 
| Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT |  | Week 12. | 
| Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable. | Baseline to Week 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-interventional, mild to moderate Alzheimer's, ARICEPT.