An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01066546
• Other study ID #: B1451030
• Status: Terminated
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: August 30, 2012
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Dimebon tablet for oral administration
10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Costa Mesa	California
United States	Pfizer Investigational Site	Delray Beach	Florida
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Los Alamitos	California
United States	Pfizer Investigational Site	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Baseline up to 4 weeks after last dose of study treatment	Yes
Secondary	Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26	SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis (0-8), visuospatial ability (0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score=greater cognitive impairment.	Baseline, Week 6, 12, 26	No
Secondary	Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26	ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.	Baseline, Week 6, 12, 26	No
Secondary	Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26	MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; ranged from 0 to 30, higher score indicates better cognitive state.	Baseline, Week 12, 26	No
Secondary	Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26	NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.	Baseline, Week 6, 12, 26	No
Secondary	Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26	NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer's Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.	Week 26	No
Secondary	Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26	RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver's job. Overall cost of care was evaluated to quantify the resources utilized.	Baseline, Week 12, 26	No
Secondary	Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Total possible score is sum of individual items, ranged from 5 to 15; lower score indicated a better health state.	Baseline, Week 12, 26	No

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