Study of Combination Therapy With Dimebon and Donepezil (... | NCT00704782

Studies
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease

NCT00704782

Sponsor

Medivation, Inc.

Status

Terminated

Last Update Posted

Dec 10, 2015Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Alzheimer's Disease

Interventions

dimebon

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was halted after a Phase 3 study of dimebon failed to show efficacy.

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Jun 23, 2008

First Submission Date that Met QC Criteria

Jun 23, 2008

First Posted Date

Jun 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Nov 13, 2015

Certification/Extension First Submitted that Passed QC Review

Nov 13, 2015

Certification/Extension First Posted Date

Dec 10, 2015Estimated

Last Update Submitted Date

Nov 13, 2015

Last Update Posted Date

Dec 10, 2015Estimated

Description Module

Brief Summary

The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dimebon	Experimental	20 mg by mouth 3 times a day	Drug: dimebon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dimebon	Drug		Dimebon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety of Dimebon in combination with donepezil (Aricept)		week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Alzheimer's disease
On donepezil (Aricept)
Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

Unstable medical illnesses or significant hepatic or renal disease
Other primary psychiatric or neurological disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xenoscience, Inc.		Phoenix	Arizona	85004	United States
Banner Alzheimer's Institute

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C010119	latrepirdine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided