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Completed

NCT Number: NCT01089582

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupolis Dimokritio, Alexandroupoli, Thrace, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Alzheimer's Disease

Exclusion criteria

  • There are no exclusion criteria

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12

    Time frame: Baseline, Week 12.

    CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.

  2. Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12

    Time frame: 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?'.

  3. 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

    Time frame: 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.

  4. 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

    Time frame: 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 outcomes

  1. Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation

    Time frame: 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.

  2. Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT

    Time frame: Week 12.

  3. Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12

    Time frame: Baseline to Week 12.

    The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: QUEST

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 18, 2010
Registry last updated
Apr 28, 2011

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

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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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