A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease

NCT ID: NCT00954590

Last Updated: 2016-09-27

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.

Detailed Description

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Conditions

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Moderate to Severe Alzheimer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dimebon (latrepirdine)

Dimebon, 20 mg orally three times daily

Group Type EXPERIMENTAL

Dimebon (latrepirdine)

Intervention Type DRUG

20 mg orally three times daily

Placebo

Placebo orally three times daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo orally three times daily

Interventions

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Dimebon (latrepirdine)

20 mg orally three times daily

Intervention Type DRUG

Placebo

Placebo orally three times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate-to-Severe Alzheimer's disease
* Mini-Mental State Examination (MMSE) Score between 5 to 14, 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Medivation, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Santiago, , Chile

Site Status

Glasgow, Scotland, United Kingdom

Site Status

Countries

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Chile United Kingdom

Other Identifiers

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DIM19

Identifier Type: -

Identifier Source: org_study_id

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