A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease - NCT00890890-33613(Clinical Trial 289490)
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Tampa |
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State:
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FL |
| Zip Code: |
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33613 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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The purpose of this study is to determine the safety and tolerability of BMS-708163 in
patients with Prodromal Alzheimer's disease over a treatment period of a minimum of
104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post
treatment.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
- Memory complaint by subject or study partner
- CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
- Score of ≤4 on the Modified Hachinski Ischemia Scale
- CT results consistent with Alzheimer's disease
- Medically stable
- 6 years education
- Reliable study partner
- Must be able to swallow capsules
Exclusion Criteria:
- Premenopausal women
- DSM-IV diagnosis of Dementia History of stroke
- Immunocompromised
- Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea
or past GI surgery that would impact drug absorption
- Unstable Vitamin B-12 deficiency
- Hematologic or solid malignancy within 5 years
- Geriatric Depression Scale ≥ 6
- Unstable medical condition
- Alcohol or drug abuse history with 12-months of study entry
- Significant drug allergy
- Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled
nursing facility at entry
- Any other experimental therapy with 30-days of study entry |
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| Study is available at: |
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University Of South Florida
Tampa, FL 33613
United States
Primary Contact:
Amanda Smith, Site 029
Phone: 813-974-4355
Secondary Contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:
Email: Clinical.Trials@bms.com |
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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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March 23, 2011 |
Modifications to
this listing: |
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