A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— CONNECTION  

Official title:

A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675623
• Other study ID #: CONNECTION
• Secondary ID: DIM14
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: September 24, 2016
• Start date: May 2008

Study information

• Verified date: September 2016
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).

Description:

This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.

The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Mild-to-Moderate Alzheimer's disease

• Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)

• MMSE score 10-24 inclusive

• Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD

• Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

• Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days

• Other causes of dementia

• Other primary psychiatric or neurological disorders

• Unstable medical illnesses or significant hepatic or renal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Dimebon
Dimebon, 5 mg orally three times daily for six months
• Dimebon
Dimebon 20 mg orally three times daily for six months
• Placebo
Placebo three times daily for six months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medivation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog).		Week 26	No
Primary	To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus).		Week 26	No
Secondary	To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).		Week 26	No
Secondary	To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI).		Week 26	No