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

March 17, 2010
April 25, 2011
November 2007
July 2009   (final data collection date for primary outcome measure)
  • 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.
  • The caregivers' perception regarding the patients' overall improvement. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient's QoL was assessed at baseline using a disease specific Hr-QoL scale (quality of life for Alzheimer's dementia [QoL AD]). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The changes in overall symptoms of the patient's condition by the physician using the 7 step Clinical Global Impressions (CGI) of improvement scale. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01089582 on ClinicalTrials.gov Archive Site
  • 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.
  • The presence of various co morbid conditions was assessed at the first visit, when recording the significant medical history of the patient. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The starting dose of ARICEPT, as well as any changes in dosage during treatment during the observation period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The tolerance of ARICEPT and reported side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Termination of ARICEPT treatment during the study and the reason(s) for stopping [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Alzheimer Disease
Other: No intervention
AD patients
Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
628
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease

Exclusion Criteria:

  • There are no exclusion criteria
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01089582
A2501054
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP