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NCT Number: NCT00889603

Non-Interventional Study With Aricept® Evess

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vascular Dementia Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Bacau, Jud. Bacau, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)

    Time frame: Baseline and Week 24

    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.

Secondary outcomes

  1. Change From Baseline in MMSE Total

    Time frame: Baseline, Week 8, 16, and 24

    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.

  2. Change From Baseline in Functional Activity Questionnaire (FAQ)

    Time frame: Baseline and Week 24

    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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  7. Number of Participants in Each Patient Domain of Benefit

    Time frame: Week 24

    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').

Other outcomes

  1. Number of Participants With Treatment Tolerability

    Time frame: Week 24

    Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor

  2. Number of Participants Receiving Other Medications

    Time frame: Baseline and Week 24

    Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 29, 2009
Registry last updated
Mar 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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