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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Medivation, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00377715
First received: September 15, 2006
Last updated: December 26, 2007
Last verified: December 2007

September 15, 2006
December 26, 2007
September 2006
May 2008   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: 52 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: 52 ] [ Designated as safety issue: No ]
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
Dimebon 20 mg three times a day x 52 weeks
Experimental: 1
Intervention: Drug: Dimebon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
183
Not Provided
May 2008   (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 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 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
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00377715
DIM02
Not Provided
Mohammad Hirmand, Medivation, Inc.
Medivation, Inc.
Not Provided
Study Director: Lynn Seely, M.D. Medivation, Inc.
Medivation, Inc.
December 2007

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