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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01089582
First received: March 17, 2010
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Alzheimer Disease
Other: No intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quality Of Life Assessment In AD Patients Receiving Aricept Tablets (Donepezil Hydrochloride)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 [ Time Frame: Baseline, Week 12. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12. ] [ Designated as safety issue: No ]
    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:
  • Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation [ Time Frame: Baseline to Week 12. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 12. ] [ Designated as safety issue: No ]
  • Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 [ Time Frame: Baseline to Week 12. ] [ Designated as safety issue: Yes ]
    The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.


Enrollment: 628
Study Start Date: November 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AD patients Other: No intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease

Exclusion Criteria:

  • There are no exclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089582

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01089582     History of Changes
Other Study ID Numbers: A2501054
Study First Received: March 17, 2010
Results First Received: June 29, 2010
Last Updated: April 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
non-interventional
mild to moderate Alzheimer's
ARICEPT.

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014