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Trial record 1 of 1 for:    NCT01089582
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Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets (QUEST)

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ClinicalTrials.gov Identifier: NCT01089582
Recruitment Status : Completed
First Posted : March 18, 2010
Results First Posted : August 3, 2010
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date March 17, 2010
First Posted Date March 18, 2010
Results First Submitted Date June 29, 2010
Results First Posted Date August 3, 2010
Last Update Posted Date April 28, 2011
Study Start Date November 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2010)
  • 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.
  • 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?'.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: March 17, 2010)
  • 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 ]
  • 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 ]
  • The caregivers' perception regarding the patients' overall improvement. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01089582 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 25, 2011)
  • 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.
  • Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: March 17, 2010)
  • 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 ]
  • The starting dose of ARICEPT, as well as any changes in dosage during treatment during the observation period [ Time Frame: 12 weeks ]
  • The tolerance of ARICEPT and reported side effects [ Time Frame: 12 weeks ]
  • Termination of ARICEPT treatment during the study and the reason(s) for stopping [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality Of Life Assessment In Alzheimer's Disease (AD) Patients Receiving Aricept Tablets
Official Title Quality Of Life Assessment In AD Patients Receiving Aricept Tablets (Donepezil Hydrochloride)
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.
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
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with mild to moderate dementia of the Alzheimer's type
Condition Alzheimer Disease
Intervention Other: No intervention
Study Groups/Cohorts AD patients
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 22, 2011)
628
Original Actual Enrollment
 (submitted: March 17, 2010)
604
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease

Exclusion Criteria:

  • There are no exclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT01089582
Other Study ID Numbers A2501054
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011