Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil

NCT ID: NCT00829816

Last Updated: 2015-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-08-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dimebon

20 mg dimebon by mouth 3 times per day

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

Placebo

20 mg placebo by mouth 3 times per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Dimebon

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Alzheimer's disease
* On Memantine
* Caregiver who is willing to accompany the patient to all clinic visits

Exclusion Criteria

* Unstable medical illnesses or significant hepatic or renal disease
* Other primary psychiatric or neurological disorders
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medivation, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Los Alamitos, California, United States

Site Status

National City, California, United States

Site Status

Delray Beach, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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DIM17

Identifier Type: -

Identifier Source: org_study_id

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