An Extension of the CONCERT Protocol (DIM18) | NCT01152216

Studies
An Extension of the CONCERT Protocol (DIM18)

NCT01152216

Sponsor

Medivation, Inc.

Status

Terminated

Last Update Posted

Sep 27, 2016Estimated

Enrollment

672Actual

Phase

Phase 3

Conditions

Alzheimer's Disease

Interventions

Dimebon

Countries

Not provided

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

May 2012Actual

Completion Date

Not provided

First Submitted Date

Jun 25, 2010

First Submission Date that Met QC Criteria

Jun 28, 2010

First Posted Date

Jun 29, 2010Estimated

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

Sep 26, 2016

Certification/Extension First Submitted that Passed QC Review

Sep 26, 2016

Certification/Extension First Posted Date

Sep 27, 2016Estimated

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

Brief Summary

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

672Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dimebon	Experimental		Drug: Dimebon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dimebon	Drug	20 mg orally three times daily	Dimebon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.	Through study discontinuation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Successful completion of the 12 month DIM18 CONCERT study
Mild-to-moderate Alzheimer's disease
Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR)
Mini-Mental State Exam (MMSE) score between 12 and 24, inclusive
Stable on donepezil for at least 6 months

Exclusion Criteria:

Other causes of dementia
Major structural brain disease
Unstable medical condition or significant hepatic or renal disease

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

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