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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00377715
First received: September 15, 2006
Last updated: November 9, 2015
Last verified: November 2015

September 15, 2006
November 9, 2015
September 2005
August 2006   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Alzheimer's Disease Assessment Scale - cognitive subscale at baseline, 12 and 26 weeks
Complete list of historical versions of study NCT00377715 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression of Change [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Safety Assessed By Number of Participants With Adverse Events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Cmax: Maximum concentration
Clinical Global Impression of Change at baseline, 12, and 26 weeks.
Not Provided
Not Provided
 
Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease
Phase 2, Double-Blind, Placebo-Controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease
This study will evaluate the safety and potential benefit of Dimebon as compared to placebo in patients with mild to moderate Alzheimer's Disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Dimebon
  • Drug: Placebo
  • 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
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.
 
Completed
183
Not Provided
August 2006   (final data collection date for primary outcome measure)

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.
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00377715
DIM02
Not Provided
Not Provided
Not Provided
Medivation, Inc.
Medivation, Inc.
Not Provided
Not Provided
Medivation, Inc.
November 2015

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