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

An observational study of Alzheimer Disease, run by Pfizer at 29 sites in Greece.

Completed

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

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alzheimer Disease
How many people: 628 participants
Where: 29 sitesGreece
Study dates: Nov 2007to Jul 2009
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with mild to moderate dementia of the Alzheimer's type

Who may be able to join

Diagnosis of Alzheimer's Disease

Who cannot join

There are no exclusion criteria

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Greece29 sites

University Hospital of Alexandroupolis Dimokritio
Alexandroupoli, Thrace, 68100
General Hospital of Arta
Arta, 47-100
NIMITS (Geriatric Department)
Athens, 11-521
NIMITS Geriatric Department
Athens, 11-521
General Hospital of Athens Laikon Dementia Department
Athens, 11-527
Naval Hospital, Dementia Department
Athens, 115-21
General State Hospital "G. Genimatas", Neurology Department
Athens, 11527
ATTIKON University General Hospital (Dementia Department)
Athens, 124-62
Psychiatric Hospital of Attica Dromokaiteio, Psychiatric Department
Athens, 12461
1st IKA Hospital Neurology Clinic
Athens, 151 27
Sismanogleio Psychiatric Clinic
Athens, 151-26
HYGEIA Diagnostic & Therapeutic Center of Athens Internal Medicine Department
Athens, 15123
251 General air force hospital
Athens
Psychiatric Hospital, Psychogeriatric Clinic
Chaïdári, 124-22
Venizeleio General Hospital
Crete, 710-01
Hospital of Chania
Crete, 731-00
Hospital of Giannitsa
Giannitsá
University General Hospital
Ioannina, 45-000
General Hospital of Ioannina
Ioannina, 45-001
Center of Psychiatric Health of Katerini
Katerini, 60-100
General Hospital Neurological Clinic
Kavala, 652-01
Ag. Andreas
Pátrai, 260-00
A.H.E.P.A University General Hospital of Thessaloniki
Thessaloniki, 546 36
B´ IKA Panagia Hospital, Dementia Departments
Thessaloniki, 551-32
Papageorgiou hospital
Thessaloniki, 562-49
Psychiatric hospital, 1st Psychogeriatric Department
Thessaloniki, 564-29
Psychiatric Hospital of Thessaloniki, Psychiatric Department
Thessaloniki, 56429
G. Papanikolaou Hospital 3rd Neurology Clinic
Thessaloniki, 57010
Centre of Psychiatric Health
Tripoli, 221-00

Other trials in Greece

About this study

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

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.

Read the detailed 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.

Conditions: Alzheimer Disease
Being tested: No intervention
Keywords: non-interventional, mild to moderate Alzheimer's, ARICEPT.
Medical subject headings: Alzheimer Disease

What participants receive

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

No interventionOther

Study groups in NCT01089582
Study group	Role	What they receive
AD patients		Not described Receives: Other: No intervention

What is being measured

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

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.
Measured: Baseline, Week 12.
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?'.
Measured: Baseline, Week 12.
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.
Measured: Baseline, Week 12.
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.
Measured: Baseline, Week 12.

Secondary outcomes (3)

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.
Measured: Baseline to Week 12.
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
Measured: Week 12.
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.
Measured: Baseline to Week 12.

Timeline

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

Nov 2007Jul 2009

First posted18 Mar 2010 (estimated)
Study startNov 2007
Primary completionJul 2009
Study completionJul 2009

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 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
Time perspective: Prospective
Enrolment: 628 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01089582
Sponsor's protocol ID: A2501054
Acronym: QUEST
Status last verified: Apr 2011
First submitted: 17 Mar 2010
Last updated: 28 Apr 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quality Of Life Assessment In AD Patients Receiving Aricept Tablets (Donepezil Hydrochloride)
ClinicalTrials.gov ID: NCT01089582
Acronym / sponsor ID: QUEST / A2501054
Conditions: Alzheimer Disease
Keywords: non-interventional, mild to moderate Alzheimer's, ARICEPT.
Study type: Observational
Recruitment status: Completed
Enrolment: 628 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 18 Mar 2010 (estimated)
Results: Posted 3 Aug 2010

Clinical summary

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

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.

Detailed 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.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
AD patients	–	Other: No intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with mild to moderate dementia of the Alzheimer's type

Key inclusion criteria (1 listed)

Diagnosis of Alzheimer's Disease

Key exclusion criteria (1 listed)

There are no exclusion criteria

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
No intervention	Other	AD patients

Primary outcome

Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
Time frame: Baseline, Week 12.
CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
Time frame: Baseline, 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?'.
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
Time frame: Baseline, 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.
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
Time frame: Baseline, 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.

3 secondary outcomes

Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
Time frame: Baseline to Week 12.
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
Time frame: Week 12.
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
Time frame: Baseline to Week 12.

Results and safety

Results posted to the registry on 3 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARICEPT	603	573

Primary outcome: Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12

Time frame: Baseline, Week 12.. Number. Unit: participants

Measure	ARICEPT n = 603
Missing	26
Not assessed	5
Very much improved	27
Much improved	103
Minimally improved	277
No change	142
Minimally worse	20
Much worse	3

ARICEPT: p = 0.0023, Regression, Logistic

Population analysed: Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT.

Primary outcome: Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12

Time frame: Baseline, Week 12.. Number. Unit: participants

Measure	ARICEPT n = 603
Missing	39
Much improved	54
Improved	343
No change	140
Worse	27
Much worse	0

ARICEPT: p = 0.0382, Regression, Logistic

Population analysed: FAS.

Primary outcome: 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

Time frame: Baseline, Week 12.. Mean (Standard Deviation). Unit: scores on a scale

Measure	ARICEPT n = 581
Physical health	0.1 (0.51)
Energy	0.2 (0.58)
Mood	0.3 (0.70)
Living situation	0.2 (0.58)
Memory	0.3 (0.61)
Family	0.1 (0.56)
Marriage	0.1 (0.55)
Friends	0.1 (0.63)

ARICEPT: p = 0.1805, Regression, Linear
ARICEPT: p <0.0001, Regression, Linear
ARICEPT: p <0.0001, Regression, Linear

Population analysed: FAS; (n)=number of participants evaluable at baseline and Week 12.

Primary outcome: 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

Time frame: Baseline, Week 12.. Mean (Standard Deviation). Unit: scores on a scale

Measure	ARICEPT n = 564
Physical health	0.1 (0.54)
Energy	0.2 (0.65)
Mood	0.3 (0.72)
Living situation	0.2 (0.62)
Memory	0.3 (0.67)
Family	0.1 (0.52)
Marriage	0.1 (0.58)
Friends	0.1 (0.63)

ARICEPT: p = 0.0137, Regression, Linear
ARICEPT: p <0.0001, Regression, Linear
ARICEPT: p <0.0001, Regression, Linear

Population analysed: FAS; (n)=number of participants evaluable at baseline and Week 12.

3 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
ARICEPT	2 of 603 (0.3%)	39 of 603 (6.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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

29 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 Disease, run by Pfizer at 29 sites in Greece.

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 1 inclusion and 1 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 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Greece. 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 3 Aug 2010). 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?

Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 (time frame: Baseline, Week 12.). The study lists 4 primary outcomes in all. 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 NCT01089582.

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 28 Apr 2011.