NCT01066546

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 2, 2012

Completed
Last Updated

October 2, 2012

Status Verified

August 1, 2012

Enrollment Period

3 months

First QC Date

February 9, 2010

Results QC Date

July 30, 2012

Last Update Submit

August 30, 2012

Conditions

Alzheimer's Disease

Keywords

DeliriumDementiaAmnesticCognitive DisordersMental DisordersNervous System DiseasesCentral Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26

    Baseline, Week 6, 12, 26

  • Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26

    Baseline, Week 6, 12, 26

  • Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26

    Baseline, Week 12, 26

  • Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26

    Baseline, Week 6, 12, 26

  • Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26

    Week 26

  • +2 more secondary outcomes

Study Arms (1)

Dimebon

EXPERIMENTAL
Drug: Dimebon tablet for oral administration

Interventions

Dimebon tablet for oral administrationDRUG

10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Dimebon

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Costa Mesa, California, 92626, United States

Location

Pfizer Investigational Site

Encino, California, 91316, United States

Location

Pfizer Investigational Site

Los Alamitos, California, 90720, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660-2452, United States

Location

Pfizer Investigational Site

Delray Beach, Florida, 33445, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDeliriumDementiaCognitive DysfunctionMental DisordersNervous System DiseasesCentral Nervous System Diseases

Interventions

latrepirdineAdministration, Oral

Condition Hierarchy (Ancestors)

Brain DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition Disorders

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Limitations and Caveats

Results are not summarized because of early termination of the study due to modification in the development plan of the study treatment following lack of demonstration of efficacy in the completed DIM14 CONNECTION (B1451002/NCT00675623) study.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 2, 2012

Results First Posted

October 2, 2012

Record last verified: 2012-08

Locations

US(5)