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

April 25, 2011 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Arta, Greece, 47-100
        • General Hospital of Arta
      • Athens, Greece, 11-521
        • NIMITS (Geriatric Department)
      • Athens, Greece, 11-521
        • NIMITS Geriatric Department
      • Athens, Greece, 11-527
        • General Hospital of Athens Laikon Dementia Department
      • Athens, Greece, 115-21
        • Naval Hospital, Dementia Department
      • Athens, Greece, 11527
        • General State Hospital "G. Genimatas", Neurology Department
      • Athens, Greece, 124-62
        • ATTIKON University General Hospital (Dementia Department)
      • Athens, Greece, 12461
        • Psychiatric Hospital of Attica Dromokaiteio, Psychiatric Department
      • Athens, Greece, 151 27
        • 1st IKA Hospital Neurology Clinic
      • Athens, Greece, 151-26
        • Sismanogleio Psychiatric Clinic
      • Athens, Greece, 15123
        • HYGEIA Diagnostic & Therapeutic Center of Athens Internal Medicine Department
      • Athens, Greece
        • 251 General Air Force Hospital
      • Chaidari, Greece, 124-22
        • Psychiatric Hospital, Psychogeriatric Clinic
      • Crete, Greece, 710-01
        • Venizeleio General Hospital
      • Crete, Greece, 731-00
        • Hospital of Chania
      • Giannitsa, Greece
        • Hospital of Giannitsa
      • Ioannina, Greece, 45-000
        • University General Hospital
      • Ioannina, Greece, 45-001
        • General Hospital of Ioannina
      • Katerini, Greece, 60-100
        • Center of Psychiatric Health of Katerini
      • Kavala, Greece, 652-01
        • General Hospital Neurological Clinic
      • Patra, Greece, 260-00
        • Ag. Andreas
      • Thessaloniki, Greece, 546 36
        • A.H.E.P.A University General Hospital of Thessaloniki
      • Thessaloniki, Greece, 551-32
        • B´ IKA Panagia Hospital, Dementia Departments
      • Thessaloniki, Greece, 562-49
        • Papageorgiou Hospital
      • Thessaloniki, Greece, 564-29
        • Psychiatric hospital, 1st Psychogeriatric Department
      • Thessaloniki, Greece, 56429
        • Psychiatric Hospital of Thessaloniki, Psychiatric Department
      • Thessaloniki, Greece, 57010
        • G. Papanikolaou Hospital 3rd Neurology Clinic
      • Tripoli, Greece, 221-00
        • Centre of Psychiatric Health
    • Thrace
      • Alexandroupolis, Thrace, Greece, 68100
        • University Hospital of Alexandroupolis Dimokritio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with mild to moderate dementia of the Alzheimer's type

Description

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease

Exclusion Criteria:

  • There are no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AD patients
Other: No intervention

What is the study measuring?

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
Time Frame: Baseline, 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
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?'.
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
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.
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
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.
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
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.
Baseline to Week 12.
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
Time Frame: Week 12.
Week 12.
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.
Baseline to Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 25, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2501054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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