Non-Interventional Study With Aricept® Evess

NCT00889603 | Completed Results DMC

• 1 other identifier: A2501065
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Alzheimer's Disease; Vascular Dementia

Keywords

Aricept® Evess; non-interventional study; Alzheimer's Disease; Vascular Dementia; efficacy; tolerability; safety.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change From Baseline in MMSE Total

  Baseline, Week 8, 16, and 24

• Change From Baseline in Functional Activity Questionnaire (FAQ)

  Baseline and Week 24

• Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8

  Week 8

• Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16

  Week 16

• Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24

  Week 24

Other Outcomes (2)

• Number of Participants With Treatment Tolerability

  Week 24

• Number of Participants Receiving Other Medications

  Baseline and Week 24

Study Arms (1)

1

Drug: Aricept® Evess

Interventions

Aricept® Evess DRUG

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).

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be selected from those addressing psychiatrists on an outpatient bases, male / female, older than 50 years, being diagnosed with Alzheimer's Disease and Vascular Dementia, with MMSE score between 12 - 24.

You may qualify if:

• Outpatients (male / female), older than 50 years.
• Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.
• MMSE score between 12 - 24.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Pfizer Investigational Site

Bacau, Jud. Bacau, 600114, Romania

Location

Pfizer Investigational Site

Cluj-Napoca, Jud. Cluj, 400001, Romania

Location

Pfizer Investigational Site

Cluj-Napoca, Jud. Cluj, Romania

Location

Pfizer Investigational Site

Constanța, Jud. Constanta, Romania

Location

Pfizer Investigational Site

Craiova, Jud. Dolj, Romania

Location

Pfizer Investigational Site

Iași, Jud. Iasi, 700282, Romania

Location

Pfizer Investigational Site

Ploieşti, Jud. Prahova, Romania

Location

Pfizer Investigational Site

Timișoara, Jud. Timis, Romania

Location

Pfizer Investigational Site

Bucharest, 041902, Romania

Location

Pfizer Investigational Site

Bucharest, 061301, Romania

Location

Pfizer Investigational Site

Bucharest, Romania

Location

Pfizer Investigational Site

Iași, 700282, Romania

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

FAQ Change from baseline not analyzed, a note to file was issued stating it was removed from protocol but erroneously remained in statistical analysis section. Patient Domain of Benefit, Week 24 LOCF not analyzed; endpoint only collected at Week 24.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 31, 2011
• Results First Posted: March 31, 2011

Record last verified: 2011-03

Locations

RO (12)