View Clinical Trial (Medical Research Study)
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease - NCT00838110-54650(Clinical Trial 269419)
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La Crosse |
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State:
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WI |
| Zip Code: |
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54650 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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This is a multi-center, randomized, double-blind placebo-controlled safety study conducted
in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive
Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated
with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of
the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open
label extension study.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Diagnosis of Alzheimer's Disease.
- MMSE 12-26 inclusive.
- If on existing anti-dementia therapy, have been on a stable dose of anti-dementia
therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to
dosing in study.
- If not taking existing anti-dementia therapy, have not received therapy with
cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this
study.
Exclusion Criteria:
- Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma,
hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a
single lesion in a critical region [e.g., thalamus, hippocampus]).
- Have any major medical illness or unstable medical condition within six months of
screening that may interfere with the patient's ability to comply with study
procedures and abide by study restrictions.
- Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to
dosing or intend to start anti-dementia therapy during the double blind portion of
the study.
- Reside in a nursing home or assisted care facility with need for 24-hour care and
supervision. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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