Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets
QUEST
1 other identifier
observational
628
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2007
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 18, 2010
CompletedResults Posted
Study results publicly available
August 3, 2010
CompletedApril 28, 2011
April 1, 2011
1.7 years
March 17, 2010
June 29, 2010
April 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
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
Baseline to Week 12.
Study Arms (1)
AD patients
Interventions
Eligibility Criteria
Patients with mild to moderate dementia of the Alzheimer's type
You may qualify if:
- Diagnosis of Alzheimer's Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (29)
University Hospital of Alexandroupolis Dimokritio
Alexandroupoli, Thrace, 68100, Greece
General Hospital of Arta
Arta, 47-100, Greece
NIMITS (Geriatric Department)
Athens, 11-521, Greece
NIMITS Geriatric Department
Athens, 11-521, Greece
General Hospital of Athens Laikon Dementia Department
Athens, 11-527, Greece
Naval Hospital, Dementia Department
Athens, 115-21, Greece
General State Hospital "G. Genimatas", Neurology Department
Athens, 11527, Greece
ATTIKON University General Hospital (Dementia Department)
Athens, 124-62, Greece
Psychiatric Hospital of Attica Dromokaiteio, Psychiatric Department
Athens, 12461, Greece
1st IKA Hospital Neurology Clinic
Athens, 151 27, Greece
Sismanogleio Psychiatric Clinic
Athens, 151-26, Greece
HYGEIA Diagnostic & Therapeutic Center of Athens Internal Medicine Department
Athens, 15123, Greece
251 General air force hospital
Athens, Greece
Psychiatric Hospital, Psychogeriatric Clinic
Chaïdári, 124-22, Greece
Venizeleio General Hospital
Crete, 710-01, Greece
Hospital of Chania
Crete, 731-00, Greece
Hospital of Giannitsa
Giannitsá, Greece
University General Hospital
Ioannina, 45-000, Greece
General Hospital of Ioannina
Ioannina, 45-001, Greece
Center of Psychiatric Health of Katerini
Katerini, 60-100, Greece
General Hospital Neurological Clinic
Kavala, 652-01, Greece
Ag. Andreas
Pátrai, 260-00, Greece
A.H.E.P.A University General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
B´ IKA Panagia Hospital, Dementia Departments
Thessaloniki, 551-32, Greece
Papageorgiou hospital
Thessaloniki, 562-49, Greece
Psychiatric hospital, 1st Psychogeriatric Department
Thessaloniki, 564-29, Greece
Psychiatric Hospital of Thessaloniki, Psychiatric Department
Thessaloniki, 56429, Greece
G. Papanikolaou Hospital 3rd Neurology Clinic
Thessaloniki, 57010, Greece
Centre of Psychiatric Health
Tripoli, 221-00, Greece
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 18, 2010
Study Start
November 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
April 28, 2011
Results First Posted
August 3, 2010
Record last verified: 2011-04