Clinical trial NCT00675623: A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease, clinical trial, memory loss, mitochondria,
investigational drug, neurodegenerative disease, dementia
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-09
Enrollment: 598
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Week 26
measure: 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).
timeFrame: Week 26
Secondary outcomes:
measure: 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).
timeFrame: Week 26
measure: To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI).
timeFrame: Week 26
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Costa Mesa
country: United States
state: California
city: Fresno
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Hamden,
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Norwalk
country: United States
state: Connecticut
city: Hallandale Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Paducah
country: United States
state: Kentucky
city: Newton
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Brooklyn
country: United States
state: New York
city: Cedarhurst
country: United States
state: New York
city: New York City
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Morganton
country: United States
state: North Carolina
city: Centerville
country: United States
state: Ohio
city: Norristown
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Middleton
country: United States
state: Wisconsin
Study officials:
affiliation: Medivation, Inc.
name: Lynn Seely, MD
role: STUDY_DIRECTOR
References: