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

Alzheimer Disease Clinical Trial

— QUEST  

Official title:

Quality Of Life Assessment In AD Patients Receiving Aricept Tablets (Donepezil Hydrochloride)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089582
• Other study ID #: A2501054
• Status: Completed
• Phase: N/A
• First received: March 17, 2010
• Last updated: April 25, 2011
• Start date: November 2007
• Est. completion date: July 2009

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Alzheimer's Disease

Exclusion Criteria:

• There are no exclusion criteria

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis Dimokritio	Alexandroupolis	Thrace
Greece	General Hospital of Arta	Arta
Greece	1st IKA Hospital Neurology Clinic	Athens
Greece	251 General air force hospital	Athens
Greece	ATTIKON University General Hospital (Dementia Department)	Athens
Greece	General Hospital of Athens Laikon Dementia Department	Athens
Greece	General State Hospital "G. Genimatas", Neurology Department	Athens
Greece	HYGEIA Diagnostic & Therapeutic Center of Athens Internal Medicine Department	Athens
Greece	Naval Hospital, Dementia Department	Athens
Greece	NIMITS (Geriatric Department)	Athens
Greece	NIMITS Geriatric Department	Athens
Greece	Psychiatric Hospital of Attica Dromokaiteio, Psychiatric Department	Athens
Greece	Sismanogleio Psychiatric Clinic	Athens
Greece	Psychiatric Hospital, Psychogeriatric Clinic	Chaidari
Greece	Hospital of Chania	Crete
Greece	Venizeleio General Hospital	Crete
Greece	Hospital of Giannitsa	Giannitsa
Greece	General Hospital of Ioannina	Ioannina
Greece	University General Hospital	Ioannina
Greece	Center of Psychiatric Health of Katerini	Katerini
Greece	General Hospital Neurological Clinic	Kavala
Greece	Ag. Andreas	Patra
Greece	A.H.E.P.A University General Hospital of Thessaloniki	Thessaloniki
Greece	B´ IKA Panagia Hospital, Dementia Departments	Thessaloniki
Greece	G. Papanikolaou Hospital 3rd Neurology Clinic	Thessaloniki
Greece	Papageorgiou hospital	Thessaloniki
Greece	Psychiatric Hospital of Thessaloniki, Psychiatric Department	Thessaloniki
Greece	Psychiatric hospital, 1st Psychogeriatric Department	Thessaloniki
Greece	Centre of Psychiatric Health	Tripoli

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12	CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.	Baseline, Week 12.	No
Primary	Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at 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?'.	Baseline, Week 12.	No
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	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.	Baseline, Week 12.	No
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	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.	Baseline, Week 12.	No
Secondary	Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation	The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.	Baseline to Week 12.	No
Secondary	Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT		Week 12.	No
Secondary	Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12	The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.	Baseline to Week 12.	Yes

External Links

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