Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets
- Conditions
- Alzheimer Disease
- Registration Number
- NCT01089582
- Lead Sponsor
- Pfizer
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 628
- Diagnosis of Alzheimer's Disease
- There are no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 Baseline, Week 12. CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 Baseline, 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?'.
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 Baseline, 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.
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 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation Baseline to Week 12. The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.
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 Baseline to Week 12. The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.
Trial Locations
- Locations (29)
University Hospital of Alexandroupolis Dimokritio
🇬🇷Alexandroupolis, Thrace, Greece
General Hospital of Arta
🇬🇷Arta, Greece
NIMITS (Geriatric Department)
🇬🇷Athens, Greece
NIMITS Geriatric Department
🇬🇷Athens, Greece
General Hospital of Athens Laikon Dementia Department
🇬🇷Athens, Greece
Naval Hospital, Dementia Department
🇬🇷Athens, Greece
General State Hospital "G. Genimatas", Neurology Department
🇬🇷Athens, Greece
ATTIKON University General Hospital (Dementia Department)
🇬🇷Athens, Greece
Psychiatric Hospital of Attica Dromokaiteio, Psychiatric Department
🇬🇷Athens, Greece
1st IKA Hospital Neurology Clinic
🇬🇷Athens, Greece
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