Dementia, VascularPhase 3NCT00174382
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
A Phase 3 study testing Donepezil in people with Dementia, Vascular and Dementia, Mixed, run by Pfizer at 30 sites in Canada.
Trial summary
To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia, Vascular, Dementia, Mixed
- What is being tested?
- Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 30 sitesCanada
- Study dates
- Jun 2005to Apr 2008
- Phase
- Phase 3
- 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
Who may be able to join
- Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.
- Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.
Who cannot join
- Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Canada30 sites
Pfizer Investigational Site
Abbotsford British Columbia, British Columbia, V2S 3P8
Pfizer Investigational Site
Amherst Nova Scotia, Nova Scotia, B4H 4R7
Pfizer Investigational Site
Beauport, Quebec, G1J 2G3
Pfizer Investigational Site
Belvedere, Alberta, T5C 0A3
Pfizer Investigational Site
Burlington, Ontario, L7M 4Y1
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Cowansville, Quebec, J2K 2X9
Pfizer Investigational Site
Edmonton, Alberta, T5A 4L8
Pfizer Investigational Site
Edmonton, Alberta, T6A 0A5
Pfizer Investigational Site
Fort Erie, Ontario, L2A 1Z3
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2E1
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, G2E 2X1
Pfizer Investigational Site
Montreal, Quebec, H1T 2M4
Pfizer Investigational Site
North Bay, Ontario, P1B 2H3
Pfizer Investigational Site
Ottawa, Ontario, K1N 5C8
Pfizer Investigational Site
Ottawa, Ontario, K2C 3R2
Pfizer Investigational Site
Ottawa, Ontario, K2G 3Y5
Pfizer Investigational Site
Peterborough, Ontario, K9H 2P4
Pfizer Investigational Site
Pictou, Nova Scotia, B0K 1H0
Pfizer Investigational Site
Regina, Saskatchewan, S4P 3X1
Pfizer Investigational Site
Rimouski, Quebec, G5L 9A8
Pfizer Investigational Site
Saint John, New Brunswick, E2L 3L6
Pfizer Investigational Site
Saint-Jean-sur-Richelieu, Quebec, J2W 2A3
Pfizer Investigational Site
Saint-Léonard, Quebec, H1S 3A9
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Toronto, Ontario, M3B 2W7
Pfizer Investigational Site
Victoria, British Columbia, V8T 5G1
Pfizer Investigational Site
Winnipeg, Manitoba, R2H 0R8
About this study
Official title: An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. The effects of donepezil on executive functioning, behavior, general cognition, ADLs and global functioning will be assessed.
Read the detailed description
The trial was terminated on October 15, 2007 due to difficulties in recruiting the subjects. There were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.
- Conditions
- Dementia, Vascular, Dementia, Mixed
- Being tested
- Donepezil
- Medical subject headings
- Dementia, Vascular, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
Measured: Baseline, week 12, week 24
Secondary outcomes (13)
Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.
Measured: Baseline, week 12, week 24
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance \& correspondence, medications, leisure \& housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered
Measured: Baseline, 12 weeks, 24 weeks
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.
Measured: Baseline, week 12, week 24
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.
Measured: Baseline, 12 weeks, 24 weeks
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.
Measured: Baseline, 12 weeks, 24 weeks
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.
Measured: Baseline, 12 weeks, 24 weeks
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
The number of words a particpant can generate in 1 minute.
Measured: Baseline, 12 weeks, week 24
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
NPI-Q measures severity of behavioural manifestations of dementia \& the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores \& ranges from 0 to 36
Measured: Baseline, 12 weeks, 24 weeks
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60
Measured: Baseline, week 12, week 24
Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
Scale measures subject's clinical condition at baseline for severity (CGI-S) \& for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) \& 4 indicates no change from baseline
Measured: Baseline, week 24
Clinical Global Impressions Severity (CGI-S)
Scale measures subject's clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).
Measured: Baseline
Clinical Global Impressions Improvement (CGI-I)
Scale measures subject's clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) \& 4 indicates no change from baseline
Measured: Week (wk) 24
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Scale measures subject's (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more
Measured: Baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: See Detailed Description
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 Dementia, VascularStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174382
- Sponsor's protocol ID
- A2501026
- Status last verified
- Mar 2015
- First submitted
- 8 Sep 2005
- Last updated
- 24 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
- ClinicalTrials.gov ID
- NCT00174382
- Acronym / sponsor ID
- A2501026
- Conditions
- Dementia, Vascular, Dementia, Mixed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description
- Enrolment
- 149 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 12 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. The effects of donepezil on executive functioning, behavior, general cognition, ADLs and global functioning will be assessed.
Detailed description
The trial was terminated on October 15, 2007 due to difficulties in recruiting the subjects. There were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Donepezil |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.
- Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.
Key exclusion criteria (1 listed)
- Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.
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 |
|---|---|---|
| Donepezildonepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks | Drug | 1 |
Primary outcome
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
Time frame: Baseline, week 12, week 24
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
13 secondary outcomes
Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
Time frame: Baseline, week 12, week 24
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
Time frame: Baseline, 12 weeks, 24 weeks
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
Time frame: Baseline, week 12, week 24
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
Time frame: Baseline, 12 weeks, 24 weeks
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
Time frame: Baseline, 12 weeks, 24 weeks
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
Time frame: Baseline, 12 weeks, 24 weeks
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
Time frame: Baseline, 12 weeks, week 24
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
Time frame: Baseline, 12 weeks, 24 weeks
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
Time frame: Baseline, week 12, week 24
Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
Time frame: Baseline, week 24
Clinical Global Impressions Severity (CGI-S)
Time frame: Baseline
Clinical Global Impressions Improvement (CGI-I)
Time frame: Week (wk) 24
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Time frame: Baseline, week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- 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
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Donepezil in people with Dementia, Vascular and Dementia, Mixed, run by Pfizer at 30 sites in Canada.
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 2 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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2009). 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 in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set (time frame: Baseline, week 12, week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2015.