Clinical trial NCT01066546: An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease
Official title: An Open-Label Extension To The B1451006 Protocol To Evaluate The Safety And Efficacy Of Dimebon (Latrepirdine, PF-01913539) In Subjects With Moderate-To-Severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Delirium
Dementia
Amnestic
Cognitive Disorders
Mental Disorders
Nervous System Diseases
Central Nervous System Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2010-02-10
Enrollment: 5
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe Alzheimer's Disease.

Detailed description: This study was terminated on May 7, 2010 due to modification of the dimebon development plan, following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Eligibility criteria: Inclusion Criteria:

* Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon study

Exclusion Criteria:

* Any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to 4 weeks after last dose of study treatment
Secondary outcomes:
measure: Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26
timeFrame: Baseline, Week 6, 12, 26
measure: Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26
timeFrame: Baseline, Week 6, 12, 26
measure: Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26
timeFrame: Baseline, Week 12, 26
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26
timeFrame: Baseline, Week 6, 12, 26
measure: Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26
timeFrame: Week 26
measure: Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26
timeFrame: Baseline, Week 12, 26
measure: Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16
timeFrame: Baseline, Week 12, 26
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Encino
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Delray Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: