NCT00829374

Brief Summary

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
1,003

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2009

Typical duration for phase_3

Geographic Reach
10 countries

101 active sites

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

First Submitted

Initial submission to the registry

January 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

January 23, 2009

Last Update Submit

September 24, 2016

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseaseclinical trialmitochondriamemory lossneurodegenerative diseasedementiainvestigational drug

Outcome Measures

Primary Outcomes (2)

  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    Week 52

  • Alzheimer's Disease Assessment Scale - Cognitive Subscale

    Week 52

Secondary Outcomes (4)

  • Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)

    Week 52

  • Neuropsychiatric Inventory (NPI)

    Week 52

  • Resource Utilization in Dementia Lite (RUD lite)

    Week 52

  • Euro Quality of Life 5 (EQ-5D)

    Week 52

Study Arms (3)

1

EXPERIMENTAL

Dimebon, 5 mg orally three times daily

Drug: Dimebon

2

EXPERIMENTAL

Dimebon, 20 mg orally three times daily

Drug: Dimebon

3

PLACEBO COMPARATOR

Placebo orally three times daily

Drug: Placebo comparator

Interventions

DimebonDRUG

5 mg orally three times daily

1
Placebo comparatorDRUG

Placebo orally three times daily

3

Eligibility Criteria

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

You may qualify if:

  • Mild-to-moderate Alzheimer's disease (AD)
  • Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))
  • Mini-Mental State Examination (MMSE) score between 12 and 24, inclusive
  • Stable on donepezil for at least 6 months

You may not qualify if:

  • Other causes of dementia
  • Major structural brain disease
  • Unstable medical condition or significant hepatic or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (101)

Unknown Facility

Phoenix, Arizona, 85006, United States

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Sun City, Arizona, 85351, United States

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Tucson, Arizona, 85724, United States

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Costa Mesa, California, 92626, United States

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Encino, California, 91316, United States

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Escondido, California, 92025, United States

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Fresno, California, 93720, United States

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Garden Grove, California, 92845, United States

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La Jolla, California, 92037, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90095, United States

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Martinez, California, 94553, United States

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Newport, California, 92660, United States

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Paramount, California, 90723, United States

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Pasadena, California, 91105, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94143, United States

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Boulder, Colorado, 80304, United States

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Denver, Colorado, 80218, United States

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New Haven, Connecticut, 06510, United States

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Washington D.C., District of Columbia, 20057, United States

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Deerfield Beach, Florida, 33064, United States

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Delray Beach, Florida, 33445, United States

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Jacksonville, Florida, 32224, United States

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Miami, Florida, 33137, United States

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Orlando, Florida, 32806, United States

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Atlanta, Georgia, 30329, United States

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Honolulu, Hawaii, 96814, United States

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Indianapolis, Indiana, 46260, United States

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Lexington, Kentucky, 40536, United States

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Eaton, Maryland, 21601, United States

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Boston, Massachusetts, 02118, United States

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Ann Arbor, Michigan, 48105, United States

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Las Vegas, Nevada, 89106, United States

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Mount Arlington, New Jersey, 07865, United States

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Princeton, New Jersey, 08540, United States

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Albany, New York, 12208, United States

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Cedarhurst, New York, 11516, United States

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New York, New York, 10029, United States

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Rochester, New York, 14620, United States

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Durham, North Carolina, 27710, United States

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Beachwood, Ohio, 44122, United States

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Toledo, Ohio, 43623, United States

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Jenkintown, Pennsylvania, 19046, United States

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Norristown, Pennsylvania, 19401, United States

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Providence, Rhode Island, 02906, United States

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Austin, Texas, 78757, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Charlottesville, Virginia, 22903, United States

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Seattle, Washington, 98108, United States

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Middleton, Wisconsin, 53562, United States

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Newcastle, New South Wales, Australia

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Sydney, New South Wales, Australia

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Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

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Geelong, Victoria, Australia

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Melbourne, Victoria, Australia

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Perth, Western Australia, Australia

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Antwerp, Belgium

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Leuven, Belgium

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Sint-Truiden, Belgium

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Kuppio, Finland

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Oulu, Finland

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Turku, Finland

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Bordeaux, France

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Concert, France

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Lille, France

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Montpellier, France

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Nice, France

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Toulouse, France

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Berlin, Germany

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Bochum, Germany

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Freiburg im Breisgau, Germany

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Hattingen, Germany

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Mannheim, Germany

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Munich, Germany

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Brescia, Italy

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Florence, Italy

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Genoa, Italy

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Perugia, Italy

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Rome, Italy

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Christchurch, Canterbury, New Zealand

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Auckland, New Zealand

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Malmo, Sweden

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Norrköping, Sweden

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Stockholm, Sweden

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Brentford, Middlesex, United Kingdom

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Rushden, Northhamptonshire, United Kingdom

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Glasgow, Scotland, United Kingdom

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Worthington, West Sussex, United Kingdom

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Bath, United Kingdom

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Blackpool, United Kingdom

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Bradford, United Kingdom

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Greater Manchester, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Norfolk, United Kingdom

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Oxford, United Kingdom

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Southampton, United Kingdom

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Swindon, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer DiseaseMemory DisordersNeurodegenerative DiseasesDementia

Interventions

latrepirdine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 27, 2009

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

AU(7)DE(6)FI(3)SE(3)US(52)IT(5)NZ(2)GB(14)BE(3)FR(6)