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
Results First Received: June 29, 2010  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Alzheimer Disease
Intervention: Other: No intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ARICEPT ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.

Participant Flow:   Overall Study
    ARICEPT  
STARTED     603  
COMPLETED     573 [1]
NOT COMPLETED     30  
Death                 2  
Adverse Event                 15  
Lost to Follow-up                 8  
Unspecified                 4  
Withdrawal by Subject                 1  
[1] 1 subject died during the study; 1 subject died following permanent discontinuation from the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ARICEPT ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.

Baseline Measures
    ARICEPT  
Number of Participants  
[units: participants]
  603  
Age, Customized  
[units: participants]
 
18 to 44 years     6  
45 to 64 years     44  
65 years or older     543  
Unspecified     10  
Gender, Customized  
[units: participants]
 
Female     364  
Male     238  
Unspecified     1  
Medical History [1]
[units: participants]
 
Anaemia     4  
Iron deficiency anaemia     3  
Aortic valve incompetence     1  
Arrhythmia     1  
Atrial fibrillation     7  
Cardiac failure     1  
Coronary artery disease     64  
Thalassaemia trait     1  
Vertigo     4  
Goitre     3  
Hyperthyroidism     7  
Hypothyroidism     16  
Cataract     4  
Eye disorder     1  
Glaucoma     1  
Colitis     1  
Diverticulum     1  
Diverticulum intestinal     1  
Gastrooesophageal reflux disease     3  
Pancreatitis chronic     1  
Necrosis     1  
Sarcoidosis     1  
Erysipelas     1  
Panencephalitis     1  
Traumatic brain injury     1  
Vitamin B12 decreased     1  
Diabetes mellitus     89  
Dyslipidaemia     1  
Hypercholesterolaemia     2  
Hyperlipidaemia     129  
Hyperuricaemia     3  
Arthritis     2  
Arthropathy     1  
Musculoskeletal pain     1  
Osteoarthritis     4  
Osteoporosis     33  
Rheumatoid arthritis     3  
Haemangioma     1  
Prostate cancer     3  
Carotid artery disease     1  
Cerebral ischaemia     51  
Cerebrovascular accident     16  
Dementia     2  
Diabetic neuropathy     1  
Dystonia     1  
Epilepsy     7  
Extrapyramidal disorder     3  
Headache     1  
Migraine     2  
Motor neurone disease     1  
Multiple sclerosis     2  
Myasthenia gravis     1  
Parkinson’s disease     16  
Polyneuropathy     2  
Sciatica     2  
Tremor     1  
Abnormal behaviour     2  
Anxiety disorder     3  
Bipolar disorder     1  
Depression     116  
Neurosis     2  
Personality change due to a general medical condit     1  
Phobia     1  
Psychotic disorder     3  
Psychotic disorder due to a general medical condit     2  
Schizophrenia     11  
Schizophrenia, paranoid type     1  
Sleep disorder     3  
Stress     2  
Glomerulonephritis     1  
Incontinence     1  
Renal failure     1  
Renal failure chronic     2  
Urinary incontinence     2  
Urinary retention     1  
Benign prostatic hyperplasia     9  
Prostatic disorder     1  
Prostatomegaly     9  
Asthma     4  
Chronic obstructive pulmonary disease     13  
Lichen sclerosus     1  
Cardiac operation     1  
Cardiac pacemaker insertion     1  
Oesophageal operation     1  
Arterial disorder     1  
Hypertension     273  
Temporal arteritis     1  
Varicose vein     1  
Venous insufficiency     1  
[1] Participants were counted once per medical history but could be counted in more than one medical history.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12   [ Time Frame: Baseline, Week 12. ]

2.  Primary:   Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12   [ Time Frame: Baseline, Week 12. ]

3.  Primary:   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. ]

4.  Primary:   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. ]

5.  Secondary:   Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation   [ Time Frame: Baseline to Week 12. ]

6.  Secondary:   Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT   [ Time Frame: Week 12. ]

7.  Secondary:   Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12   [ Time Frame: Baseline to Week 12. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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