Non-Interventional Study With Aricept® Evess

An observational study of Alzheimer's Disease and Vascular Dementia, run by Pfizer at 12 sites in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Alzheimer's Disease, Vascular Dementia
What is being tested?: Aricept® Evess
Type of treatment: Pill or oral medicine
How many people: 370 participants
Where: 12 sitesRomania
Study dates: May 2009to Mar 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Romania12 sites

Pfizer Investigational Site
Bacau, Jud. Bacau, 600114
Pfizer Investigational Site
Bucharest, 041902
Pfizer Investigational Site
Bucharest, 061301
Pfizer Investigational Site
Bucharest
Pfizer Investigational Site
Cluj-Napoca, Jud. Cluj, 400001
Pfizer Investigational Site
Cluj-Napoca, Jud. Cluj
Pfizer Investigational Site
Constanța, Jud. Constanta
Pfizer Investigational Site
Craiova, Jud. Dolj
Pfizer Investigational Site
Iași, Jud. Iasi, 700282
Pfizer Investigational Site
Iași, 700282
Pfizer Investigational Site
Ploieşti, Jud. Prahova
Pfizer Investigational Site
Timișoara, Jud. Timis

Other trials in Romania

About this study

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

Conditions: Alzheimer's Disease, Vascular Dementia
Being tested: Aricept® Evess
Keywords: Aricept® Evess, non-interventional study, Alzheimer's Disease, Vascular Dementia, efficacy, tolerability, safety.
Medical subject headings: Alzheimer Disease, Dementia, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aricept® EvessDrug
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).

Study groups in NCT00889603
Study group	Role	What they receive
1		Not described Receives: Drug: Aricept® Evess

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 24

Secondary outcomes (7)

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.
Measured: Baseline, Week 8, 16, and 24
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.
Measured: Baseline and Week 24
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.
Measured: Week 8
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.
Measured: Week 16
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.
Measured: Week 24
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.
Measured: Week 24
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').
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Mar 2010

First posted29 Apr 2009 (estimated)
Study startMay 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00889603
Sponsor's protocol ID: A2501065
Status last verified: Mar 2011
First submitted: 27 Apr 2009
Last updated: 31 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia
ClinicalTrials.gov ID: NCT00889603
Acronym / sponsor ID: A2501065
Conditions: Alzheimer's Disease, Vascular Dementia
Keywords: Aricept® Evess, non-interventional study, Alzheimer's Disease, Vascular Dementia, efficacy, tolerability, safety.
Study type: Observational
Recruitment status: Completed
Enrolment: 370 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 29 Apr 2009 (estimated)
Results: Posted 31 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Drug: Aricept® Evess

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aricept® Evess5 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).	Drug	1

Primary outcome

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.

7 secondary outcomes

Change From Baseline in MMSE Total
Time frame: Baseline, Week 8, 16, and 24
Change From Baseline in Functional Activity Questionnaire (FAQ)
Time frame: Baseline and Week 24
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8
Time frame: Week 8
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16
Time frame: Week 16
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24
Time frame: Week 24
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF
Time frame: Week 24
Number of Participants in Each Patient Domain of Benefit
Time frame: Week 24

Results and safety

Results posted to the registry on 31 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Donepezil	370	333

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

Time frame: Baseline and Week 24. Mean (Standard Error). Unit: Scores on a scale

Measure	Donepezil n = 351
Value	1.92 (0.14)

Donepezil: Mean Difference (Net): 1.92 (95% CI 1.65 to 2.20)

Population analysed: Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Donepezil	12 of 370 (3.2%)	52 of 370 (14.1%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease and Vascular Dementia, run by Pfizer at 12 sites in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF) (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00889603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2011.