Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia - Clinical Trial for Dementia, Vascular | NCT00174382

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Donepezil

About this trial

This is an interventional treatment trial for Dementia, Vascular

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

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.

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.

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.

Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)

The number of words a particpant can generate in 1 minute.

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

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

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

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).

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

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

Full Information

NCT ID

NCT00174382

First Posted

September 8, 2005

Last Updated

March 4, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00174382

Brief Title

Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Official Title

An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Terminated

Why Stopped

See Detailed Description

Study Start Date

June 2005 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia, Vascular, Dementia, Mixed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Donepezil

Intervention Description

donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks

Primary Outcome Measure Information:

Title

Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set

Description

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.

Time Frame

Baseline, week 12, week 24

Secondary Outcome Measure Information:

Title

Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.

Description

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.

Time Frame

Baseline, week 12, week 24

Title

Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.

Description

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

Time Frame

Baseline, 12 weeks, 24 weeks

Title

Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)

Description

DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.

Time Frame

Baseline, week 12, week 24

Title

Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)

Description

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.

Time Frame

Baseline, 12 weeks, 24 weeks

Title

Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)

Description

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.

Time Frame

Baseline, 12 weeks, 24 weeks

Title

CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)

Description

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.

Time Frame

Baseline, 12 weeks, 24 weeks

Title

Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)

Description

The number of words a particpant can generate in 1 minute.

Time Frame

Baseline, 12 weeks, week 24

Title

Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)

Description

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

Time Frame

Baseline, 12 weeks, 24 weeks

Title

Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)

Description

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

Time Frame

Baseline, week 12, week 24

Title

Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)

Description

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

Time Frame

Baseline, week 24

Title

Clinical Global Impressions Severity (CGI-S)

Description

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).

Time Frame

Baseline

Title

Clinical Global Impressions Improvement (CGI-I)

Description

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

Time Frame

Week (wk) 24

Title

Clinical Global Impressions Improvement (CGI-I) Dichotomized Response

Description

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

Time Frame

Baseline, week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Belvedere

State/Province

Alberta

ZIP/Postal Code

T5C 0A3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5A 4L8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6A 0A5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Abbotsford

State/Province

British Columbia

ZIP/Postal Code

V2S 3P8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Coquitlam

State/Province

British Columbia

ZIP/Postal Code

V3K 3P4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8T 5G1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2H 0R8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Saint John

State/Province

New Brunswick

ZIP/Postal Code

E2L 3L6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Amherst

State/Province

Nova Scotia

ZIP/Postal Code

B4H 4R7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2E1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Pictou

State/Province

Nova Scotia

ZIP/Postal Code

B0K 1H0

Country

Canada

Facility Name

Pfizer Investigational Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7M 4Y1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Corunna

State/Province

Ontario

ZIP/Postal Code

N0N 1G0

Country

Canada

Facility Name

Pfizer Investigational Site

City

Fort Erie

State/Province

Ontario

ZIP/Postal Code

L2A 1Z3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hawkesbury

State/Province

Ontario

ZIP/Postal Code

K6A 1A1

Country

Canada

Facility Name

Pfizer Investigational Site

City

North Bay

State/Province

Ontario

ZIP/Postal Code

P1B 2H3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 5C8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2C 3R2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2G 3Y5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9H 2P4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Sarnia

State/Province

Ontario

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3B 2W7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Beauport

State/Province

Quebec

ZIP/Postal Code

G1J 2G3

Country

Canada

Facility Name

Pfizer Investigational Site

City

Cowansville

State/Province

Quebec

ZIP/Postal Code

J2K 2X9

Country

Canada

Facility Name

Pfizer Investigational Site

City

L'Ancienne-Lorette

State/Province

Quebec

ZIP/Postal Code

G2E 2X1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Pfizer Investigational Site

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 9A8

Country

Canada

Facility Name

Pfizer Investigational Site

City

St-Jean-sur-Richelieu

State/Province

Quebec

ZIP/Postal Code

J2W 2A3

Country

Canada

Facility Name

Pfizer Investigational Site

City

St. Leonard

State/Province

Quebec

ZIP/Postal Code

H1S 3A9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4P 3X1

Country

Canada

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2501026&StudyName=Vaspect%20Study%20-%20An%20Open-Label%20Trial%20Of%20Donepezil%20in%20Vascular%20and%20Mixed%20Dementia

Description

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

Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Dementia, Vascular, Dementia, Mixed

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial