Non-Interventional Study With Aricept® Evess

Alzheimer's Disease Clinical Trial

Official title:

Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889603
• Other study ID #: A2501065
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: March 4, 2011
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Ethics Committee and National Medicine Agency
• Study type: Observational

Clinical Trial Summary

The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week length of the study aims to collect data from a large number of patients (n= 400) on the safety and efficacy at the usual dosage of the product providing an overview of Aricept® Evess profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Outpatients (male / female), older than 50 years.

• Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.

• MMSE score between 12 - 24.

Exclusion Criteria:

• Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives or any of the excipients of Aricept® Evess.

• Patients with severe impaired hepatic function.

• Patients with pre-existing gastrointestinal ulcer disease.

• Patients with the history of bronchial asthma or chronic obstructive lung disease.

• Patients with the history of serious atrioventricular conduction disturbances.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Drug:
• Aricept® Evess
5 mg film-coated orodispersible tablets, 10 mg film-coated orodispersible tablets. Treatment may be started with 5 mg donepezil/ day (once-a-day dosing) and after four weeks can be titrated to 10 mg/day (once-a-day dosing).

Locations

Country	Name	City	State
Romania	Pfizer Investigational Site	Bacau	Jud. Bacau
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Cluj-Napoca	Jud. Cluj
Romania	Pfizer Investigational Site	Cluj-Napoca	Jud. Cluj
Romania	Pfizer Investigational Site	Constanta	Jud. Constanta
Romania	Pfizer Investigational Site	Craiova	Jud. Dolj
Romania	Pfizer Investigational Site	Iasi	Jud. Iasi
Romania	Pfizer Investigational Site	Iasi
Romania	Pfizer Investigational Site	Ploiesti	Jud. Prahova
Romania	Pfizer Investigational Site	Timisoara	Jud. Timis

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.	Baseline and Week 24	No
Secondary	Change From Baseline in MMSE Total	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.	Baseline, Week 8, 16, and 24	No
Secondary	Change From Baseline in Functional Activity Questionnaire (FAQ)	Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.	Baseline and Week 24	No
Secondary	Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Week 8	No
Secondary	Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Week 16	No
Secondary	Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Week 24	No
Secondary	Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF	CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Week 24	No
Secondary	Number of Participants in Each Patient Domain of Benefit	Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no').	Week 24	No

External Links

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