View Clinical Trial (Medical Research Study)
Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia - NCT01012830-68105(Clinical Trial 400788)
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| City: |
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Omaha |
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State:
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NE |
| Zip Code: |
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68105 |
| Conditions: |
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Schizophrenia - Dementia |
| Purpose: |
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Use Huperzine-A, a herbal supplement normally used for treatment of Alzheimer's disease, to
potentially improve cognitive dysfunction (memory problems) and functional capacity (ability
to perform common daily tasks such as cooking, bathing, telephone, shopping) in people with
schizophrenia.
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| Study summary: |
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HupA, an alkaloid initially identified from the Chinese herbal medicine Huperia serrata, is
a potent reversible acetyl cholinesterase (AChE) inhibitor with additional unique properties
including NMDA-receptor antagonist properties, neuroprotective and antioxidant effects. In
animal studies, HupA was shown to possess greater inhibitory, longer-lasting, and more
selective effects on AChE activity than donepezil. In clinical studies HupA improved memory,
mood, and activities of daily living in patients with Alzheimer's dementia. Adverse effects
have been reported at a very low rate in all the clinical trials, and are mainly
cholinergic, such as dizziness, nausea, gastrointestinal symptoms, headaches and depressed
heart rate. Thus, HupA is an attractive option which may have beneficial effects not only on
cognitive but also functional domains of schizophrenia. |
| Criteria: |
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Inclusion Criteria:
1. age 19-59
2. diagnosis of schizophrenia by MINI
3. cognition score 1 standard deviation below published norms in controls
4. clinically stable for 12 weeks i.e. on the same antipsychotic(s) for 8 weeks and
stable dose for at least 4 weeks
5. have no more than moderate severity rating on hallucinations, delusions formal
thought disorder (BPRS), negative symptoms (PANSS_N)
6. minimal EPS (Simpson-Angus <6)
7. minimal depression (Calgary <10)
8. stable dose of other psychotropics (2 months)
9. not pregnant.
Exclusion Criteria:
1. history of active peptic ulcer disease within 1 year of screening
2. clinically significant cardiac arrhythmia
3. resting pulse less than 50
4. active cancer (skin tumors other than melanoma are not excluded)
5. history of clinically significant stroke
6. current evidence or history in the past 2 years of epilepsy, focal brain lesion
7. start of cholinesterase inhibitors/ cognitive enhancers (galantamine, rivastigmine,
donepezil, vitamin E and memantine) within 2 months of screening, 8. use of
medications with significant central nervous system anticholinergic activity within 2
months of screening. |
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| Study is available at: |
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Veterans Affairs Nebraska Western Iowa Health Care System
Omaha, NE 68105
United States
Primary Contact:
Daniel A Ramirez, BS
Email: Daniel.Ramirez@va.gov
Phone: 800-451-5796 |
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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 |
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