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

Medivation

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: Dimebon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00675623

CONNECTION

DIM14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 598 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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598 participants in 3 patient groups, including a placebo group

A

Experimental group

Description:

Dimebon, 5 mg orally three times daily

Treatment:

Drug: Dimebon

Drug: Dimebon

B

Experimental group

Description:

Dimebon 20 mg orally three times daily

Treatment:

Drug: Dimebon

Drug: Dimebon

C

Placebo Comparator group

Description:

Placebo orally three times daily for six months

Treatment:

Drug: Placebo