Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets (QUEST)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01089582
First received: March 17, 2010
Last updated: April 25, 2011
Last verified: April 2011
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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
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 May 22, 2013