Clinical trial NCT00912288: A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 26-Week Trial To Evaluate The Efficacy And Safety Of Dimebon In Patients With Moderate-To-Severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer Disease
Keywords: Alzheimer disease moderate-to-severe memantine safety and efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-06-03
Enrollment: 86
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: No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

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:

* Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.
* Have a Mini-Mental State Exam between 5 and 14 inclusive.
* Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.
* Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.

Exclusion Criteria:

* Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.
* Dementia other than Alzheimers disease.
* Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.

Primary outcomes:
measure: Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26
timeFrame: Baseline, Week 26
measure: Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI
timeFrame: Week 26
measure: Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26
timeFrame: Baseline, Week 26
measure: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores
timeFrame: Week 26
measure: Resource Utilization in Dementia-Lite Version (RUD-Lite)
timeFrame: Baseline, Weeks 12, 18, 26
measure: Euro Quality of Life - 5 Domain (EQ-5D) Assessment
timeFrame: Baseline, Weeks 12, 26
measure: Population Pharmacokinetic (PK) Analysis
timeFrame: Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 30 (follow-up)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
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: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Brooksville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Delray Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Pittsfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Princeton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Norristown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Cordova
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Middleton
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bochum
country: Germany
facility: Pfizer Investigational Site
city: Guenzburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Mittweida
country: Germany
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Szekesfehervar
country: Hungary
facility: Pfizer Investigational Site
city: Amadora
country: Portugal
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Michalovce
country: Slovakia
facility: Pfizer Investigational Site
city: Roznava
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Algorta, Getxo
country: Spain
facility: Pfizer Investigational Site
state: Bilbao
city: Salt
country: Spain
facility: Pfizer Investigational Site
state: Girona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Kocaeli
country: Turkey
facility: Pfizer Investigational Site
city: Samsun
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: