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Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

Dimebon

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Dimebon, Alzheimer's Disease, Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

Eligibility Criteria

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

Inclusion Criteria:

Males or females greater than or equal to 50 years of age.
Diagnosis of Alzheimer's Disease according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) and Mini Mental State Exam between 10 and 24, inclusive and Modified Hachinski Ischemia Score less than or equal to 4.
Brain imaging such as MRI and/or CT within one year of enrollment.
Subjects must have a guardian or caregiver who assists the subject at least 5 days per week (at least 3 hours/day).
Subjects must be able to cooperate with drug administration (including the ability to ingest oral medications) and study procedures and abide by study restrictions.
Subjects must have at least 6 years of prior education and should have previously (in pre-Alzheimer's condition) been capable of reading, writing and communicating effectively with others.
Subjects must be willing and able to give informed consent or have a mentally competent legal representative authorized to provide informed consent on their behalf.
Residence in an assisted care facility is allowed if subject is living independently.

Exclusion Criteria:

Major structural brain disease
Major medical illness or unstable medical condition within 6 months of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions.
Residence in a nursing home or assisted care facility that provides the subject with 24-hour care and supervision.
Women who are pregnant, nursing, or if of child-bearing potential not using a medically accepted, highly effective method of birth control.
Active alcohol dependence or drug abuse.
Use of the following medications within 60 days prior to enrollment:cognition enhancing agents, narcotic analgesics, low potency neuroleptics, antihypertensive agents with frequent Central Nervous System (CNS) side effects, anti-Parkinsonian medications, medications with central anticholinergic activity, medications for epilepsy, lithium.
Participation in an investigational drug or device study within 30 days prior to study entry, or 60 days prior to study entry if the investigational drug study involved therapy for Alzheimer's Disease.

Sites / Locations

Mental Health Research Center of Russian Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dimebon

Placebo

Arm Description

Dimebon 20 mg three times a day x 26 weeks

Placebo 20 mg three times a day x 26 weeks

Outcomes

Primary Outcome Measures

Alzheimer's Disease Assessment Scale - cognitive subscale

Secondary Outcome Measures

Clinical Global Impression of Change

Safety Assessed By Number of Participants With Adverse Events

Adverse events will be assessed through physical examinations, electrocardiograms, and clinical laboratory data (chemistry panel, complete blood count (CBC) with differential, and urinalysis). The incidence of adverse events will be summarized by severity and relationship to study treatment.

Pharmacokinetic (PK) parameter of Dimebon: Cmax

Cmax: Maximum concentration

Full Information

NCT ID

NCT00377715

First Posted

September 15, 2006

Last Updated

November 9, 2015

Sponsor

Medivation, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00377715

Brief Title

Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

Official Title

Phase 2, Double-Blind, Placebo-Controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medivation, Inc.

4. Oversight

5. Study Description

Brief Summary

This study will evaluate the safety and potential benefit of Dimebon as compared to placebo in patients with mild to moderate Alzheimer's Disease.

6. Conditions and Keywords

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

Alzheimer's Disease

Keywords

Dimebon, Alzheimer's Disease, Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

183 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dimebon

Arm Type

Experimental

Arm Description

Dimebon 20 mg three times a day x 26 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 20 mg three times a day x 26 weeks

Intervention Type

Drug

Intervention Name(s)

Dimebon

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Alzheimer's Disease Assessment Scale - cognitive subscale

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impression of Change

Time Frame

26 weeks

Title

Safety Assessed By Number of Participants With Adverse Events

Description

Time Frame

26 weeks

Title

Pharmacokinetic (PK) parameter of Dimebon: Cmax

Description

Cmax: Maximum concentration

Time Frame

Week 1, 2, 6, 12, 18, 24. Blood PK samples will be obtained pre-dose and 1 hour post-dose for each timepoint.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females greater than or equal to 50 years of age. Diagnosis of Alzheimer's Disease according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) and Mini Mental State Exam between 10 and 24, inclusive and Modified Hachinski Ischemia Score less than or equal to 4. Brain imaging such as MRI and/or CT within one year of enrollment. Subjects must have a guardian or caregiver who assists the subject at least 5 days per week (at least 3 hours/day). Subjects must be able to cooperate with drug administration (including the ability to ingest oral medications) and study procedures and abide by study restrictions. Subjects must have at least 6 years of prior education and should have previously (in pre-Alzheimer's condition) been capable of reading, writing and communicating effectively with others. Subjects must be willing and able to give informed consent or have a mentally competent legal representative authorized to provide informed consent on their behalf. Residence in an assisted care facility is allowed if subject is living independently. Exclusion Criteria: Major structural brain disease Major medical illness or unstable medical condition within 6 months of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions. Residence in a nursing home or assisted care facility that provides the subject with 24-hour care and supervision. Women who are pregnant, nursing, or if of child-bearing potential not using a medically accepted, highly effective method of birth control. Active alcohol dependence or drug abuse. Use of the following medications within 60 days prior to enrollment:cognition enhancing agents, narcotic analgesics, low potency neuroleptics, antihypertensive agents with frequent Central Nervous System (CNS) side effects, anti-Parkinsonian medications, medications with central anticholinergic activity, medications for epilepsy, lithium. Participation in an investigational drug or device study within 30 days prior to study entry, or 60 days prior to study entry if the investigational drug study involved therapy for Alzheimer's Disease.

Facility Information:

Facility Name

Mental Health Research Center of Russian Academy of Medical Sciences

City

Moscow

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

18640457

Citation

Doody RS, Gavrilova SI, Sano M, Thomas RG, Aisen PS, Bachurin SO, Seely L, Hung D; dimebon investigators. Effect of dimebon on cognition, activities of daily living, behaviour, and global function in patients with mild-to-moderate Alzheimer's disease: a randomised, double-blind, placebo-controlled study. Lancet. 2008 Jul 19;372(9634):207-15. doi: 10.1016/S0140-6736(08)61074-0.

Results Reference

derived

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Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

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