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A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Donepezil (Aricept)

Placebo

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

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

Inclusion Criteria:

Probable or possible Alzheimer's disease
Living in skilled nursing home

Exclusion Criteria:

Other types of dementia or psychiatric or neurologic disorders
Musculoskeletal disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score

Change from baseline in Severe Impairment Battery (SIB) total score

Secondary Outcome Measures

Change from baseline in SIB total score

Change from baseline in Neuropsychiatric Inventory (NPI) total score

Change from inclusion in Mini Mental State Examination (MMSE) total score

Change from baseline in Clinical Global Impression of Improvement (CGI-I) score

Adverse events and laboratory value changes

Change from baseline in modified ADCS-ADL-severe total score

Full Information

NCT ID

NCT00630851

First Posted

February 27, 2008

Last Updated

March 4, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00630851

Brief Title

A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

Official Title

A Six-month, Multicenter, Double-blind, Parallel, Placebo-controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.

6. Conditions and Keywords

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

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Donepezil (Aricept)

Intervention Description

Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo tablets orally once daily for 6 months

Primary Outcome Measure Information:

Title

Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score

Time Frame

Month 6

Title

Change from baseline in Severe Impairment Battery (SIB) total score

Time Frame

Month 6

Secondary Outcome Measure Information:

Title

Change from baseline in SIB total score

Time Frame

Month 3

Title

Change from baseline in Neuropsychiatric Inventory (NPI) total score

Time Frame

Months 3 and 6

Title

Change from inclusion in Mini Mental State Examination (MMSE) total score

Time Frame

Month 6

Title

Change from baseline in Clinical Global Impression of Improvement (CGI-I) score

Time Frame

Months 3 and 6

Title

Adverse events and laboratory value changes

Time Frame

Months 3 and 6

Title

Change from baseline in modified ADCS-ADL-severe total score

Time Frame

Month 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Probable or possible Alzheimer's disease Living in skilled nursing home Exclusion Criteria: Other types of dementia or psychiatric or neurologic disorders Musculoskeletal disease

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

Akersberga

ZIP/Postal Code

184 33 AKERSBERGA

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Alunda

ZIP/Postal Code

747 30

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Aneby

ZIP/Postal Code

578 21

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Arsta

ZIP/Postal Code

120 54

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Avesta

ZIP/Postal Code

774 82

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Bengtsfors

ZIP/Postal Code

666 30

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Bergsjo

ZIP/Postal Code

820 70

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Boden

ZIP/Postal Code

931 64

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Borlange

ZIP/Postal Code

781 27

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Degerfors

ZIP/Postal Code

693 22

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Eskilstuna

ZIP/Postal Code

631 88

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Eskilstuna

ZIP/Postal Code

632 23

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Fritsla

ZIP/Postal Code

510 29

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Gislaved

ZIP/Postal Code

332 30

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Goteborg

ZIP/Postal Code

412 75

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Gullspang

ZIP/Postal Code

547 31

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Gustavsberg

ZIP/Postal Code

134 30

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Hedemora

ZIP/Postal Code

776 28

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Helsingborg

ZIP/Postal Code

254 43

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Ingelstad

ZIP/Postal Code

360 44

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Jönköping

ZIP/Postal Code

553 16

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Kalix

ZIP/Postal Code

952 82

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Karlstad

ZIP/Postal Code

656 37

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Katrineholm

ZIP/Postal Code

641 47

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Kristinehamn

ZIP/Postal Code

681 29

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Lidkoping

ZIP/Postal Code

531 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Malmo

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Munkfors

ZIP/Postal Code

684 23

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Nassjo

ZIP/Postal Code

576 81

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Ostersund

ZIP/Postal Code

831 31

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Oxie

ZIP/Postal Code

238 40

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Partille

ZIP/Postal Code

43323

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Rattvik

ZIP/Postal Code

795 21

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Sandviken

ZIP/Postal Code

811 60

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Saro

ZIP/Postal Code

429 13

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Sjuntorp

ZIP/Postal Code

460 20

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Sollebrunn

ZIP/Postal Code

466 30

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Stockholm

ZIP/Postal Code

112 35

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Stockholm

ZIP/Postal Code

116 32

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Sunne

ZIP/Postal Code

686 22

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Trollhattan

ZIP/Postal Code

461 59

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Tullinge

ZIP/Postal Code

146 31

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Tyreso

ZIP/Postal Code

13521

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Umeå

ZIP/Postal Code

901 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Upplands Väsby

ZIP/Postal Code

194 04

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Uppsala

ZIP/Postal Code

751 25

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Varnamo

ZIP/Postal Code

33185

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Vaxjo

ZIP/Postal Code

352 41

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Visby

ZIP/Postal Code

621 84

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Vännäs

ZIP/Postal Code

911 82

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Västerås

ZIP/Postal Code

722 11

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Växjö

ZIP/Postal Code

350 04

Country

Sweden

Facility Name

Pfizer Investigational Site

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2501017&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20Aricept%20in%20patients%20with%20severe%20Alzheimer%27s%20disease%20who%20are%20living%20in%20skilled%20nursing%20homes

Description

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Learn more about this trial

A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

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A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

Alzheimer Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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