NCT00377715

Brief Summary

This study will evaluate the safety and potential benefit of Dimebon as compared to placebo in patients with mild to moderate Alzheimer's Disease.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

September 15, 2006

Last Update Submit

November 9, 2015

Conditions

Alzheimer's Disease

Keywords

Dimebon, Alzheimer's Disease, Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's Disease Assessment Scale - cognitive subscale

    26 weeks

Secondary Outcomes (3)

  • Clinical Global Impression of Change

    26 weeks

  • Safety Assessed By Number of Participants With Adverse Events

    26 weeks

  • Pharmacokinetic (PK) parameter of Dimebon: Cmax

    Week 1, 2, 6, 12, 18, 24. Blood PK samples will be obtained pre-dose and 1 hour post-dose for each timepoint.

Study Arms (2)

Dimebon

EXPERIMENTAL

Dimebon 20 mg three times a day x 26 weeks

Drug: Dimebon

Placebo

PLACEBO COMPARATOR

Placebo 20 mg three times a day x 26 weeks

Drug: Placebo

Interventions

DimebonDRUG
Dimebon
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Males or females greater than or equal to 50 years of age.
  • Diagnosis of Alzheimer's Disease according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) and Mini Mental State Exam between 10 and 24, inclusive and Modified Hachinski Ischemia Score less than or equal to 4.
  • Brain imaging such as MRI and/or CT within one year of enrollment.
  • Subjects must have a guardian or caregiver who assists the subject at least 5 days per week (at least 3 hours/day).
  • Subjects must be able to cooperate with drug administration (including the ability to ingest oral medications) and study procedures and abide by study restrictions.
  • Subjects must have at least 6 years of prior education and should have previously (in pre-Alzheimer's condition) been capable of reading, writing and communicating effectively with others.
  • Subjects must be willing and able to give informed consent or have a mentally competent legal representative authorized to provide informed consent on their behalf.
  • Residence in an assisted care facility is allowed if subject is living independently.

You may not qualify if:

  • Major structural brain disease
  • Major medical illness or unstable medical condition within 6 months of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions.
  • Residence in a nursing home or assisted care facility that provides the subject with 24-hour care and supervision.
  • Women who are pregnant, nursing, or if of child-bearing potential not using a medically accepted, highly effective method of birth control.
  • Active alcohol dependence or drug abuse.
  • Use of the following medications within 60 days prior to enrollment:cognition enhancing agents, narcotic analgesics, low potency neuroleptics, antihypertensive agents with frequent Central Nervous System (CNS) side effects, anti-Parkinsonian medications, medications with central anticholinergic activity, medications for epilepsy, lithium.
  • Participation in an investigational drug or device study within 30 days prior to study entry, or 60 days prior to study entry if the investigational drug study involved therapy for Alzheimer's Disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Research Center of Russian Academy of Medical Sciences

Moscow, Moscow, Russia

Location

Related Publications (1)

  • Doody RS, Gavrilova SI, Sano M, Thomas RG, Aisen PS, Bachurin SO, Seely L, Hung D; dimebon investigators. Effect of dimebon on cognition, activities of daily living, behaviour, and global function in patients with mild-to-moderate Alzheimer's disease: a randomised, double-blind, placebo-controlled study. Lancet. 2008 Jul 19;372(9634):207-15. doi: 10.1016/S0140-6736(08)61074-0.

    PMID: 18640457DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

latrepirdine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 18, 2006

Study Start

September 1, 2005

Primary Completion

August 1, 2006

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

RU(1)