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Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377715
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : November 11, 2015
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.

Tracking Information
First Submitted Date  ICMJE September 15, 2006
First Posted Date  ICMJE September 18, 2006
Last Update Posted Date November 11, 2015
Study Start Date  ICMJE September 2005
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2006)
Alzheimer's Disease Assessment Scale - cognitive subscale at baseline, 12 and 26 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2015)
  • Clinical Global Impression of Change [ Time Frame: 26 weeks ]
  • Safety Assessed By Number of Participants With Adverse Events [ Time Frame: 26 weeks ]
    Adverse events will be assessed through physical examinations, electrocardiograms, and clinical laboratory data (chemistry panel, complete blood count (CBC) with differential, and urinalysis). The incidence of adverse events will be summarized by severity and relationship to study treatment.
  • Pharmacokinetic (PK) parameter of Dimebon: Cmax [ Time Frame: Week 1, 2, 6, 12, 18, 24. Blood PK samples will be obtained pre-dose and 1 hour post-dose for each timepoint. ]
    Cmax: Maximum concentration
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2006)
Clinical Global Impression of Change at baseline, 12, and 26 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE Phase 2, Double-Blind, Placebo-Controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Dimebon
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Dimebon
    Dimebon 20 mg three times a day x 26 weeks
    Intervention: Drug: Dimebon
  • Placebo Comparator: Placebo
    Placebo 20 mg three times a day x 26 weeks
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2007)
183
Original Enrollment  ICMJE
 (submitted: September 15, 2006)
166
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or females greater than or equal to 50 years of age.
  2. 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.
  3. Brain imaging such as MRI and/or CT within one year of enrollment.
  4. Subjects must have a guardian or caregiver who assists the subject at least 5 days per week (at least 3 hours/day).
  5. Subjects must be able to cooperate with drug administration (including the ability to ingest oral medications) and study procedures and abide by study restrictions.
  6. 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.
  7. 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.
  8. Residence in an assisted care facility is allowed if subject is living independently.

Exclusion Criteria:

  1. Major structural brain disease
  2. 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.
  3. Residence in a nursing home or assisted care facility that provides the subject with 24-hour care and supervision.
  4. Women who are pregnant, nursing, or if of child-bearing potential not using a medically accepted, highly effective method of birth control.
  5. Active alcohol dependence or drug abuse.
  6. 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.
  7. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00377715
Other Study ID Numbers  ICMJE DIM02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medivation, Inc.
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medivation, Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP