Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Dementia	Drug: Huperzine A	Phase 4

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	15 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia
Study Start Date :	December 2009
Estimated Primary Completion Date :	December 2010
Estimated Study Completion Date :	April 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Huperzine A; 200 micrograms (mcg) of HuperzineA taken twice daily.	Drug: Huperzine A; Huperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks.; Other Names: HupA; Huperzine-A; Huperzia serrata

Outcome Measures

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Primary Outcome Measures :

1. MATRICS Consensus Cognitive Battery [ Time Frame: First visit, 4 weeks, 8 weeks ]

Secondary Outcome Measures :

1. University of California Performance Skills Assessment-Brief (UPSA-B) [ Time Frame: First visit, 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Daniel A Ramirez, BS	800-451-5796 ext 4036	Daniel.Ramirez@va.gov

Locations

United States, Nebraska
Veterans Affairs Nebraska Western Iowa Health Care System	Not yet recruiting
Omaha, Nebraska, United States, 68105
Contact: Daniel A Ramirez, BS 800-451-5796 ext 4036 Daniel.Ramirez@va.gov
Principal Investigator: Prasad R Padala, MD, MS

Sponsors and Collaborators

VA Nebraska Western Iowa Health Care System

American Legion of Iowa Foundation

Investigators

Principal Investigator:	Prasad R Padala, MD, MS	VA Office of Research and Development

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Prasad R. Padala, M.D., VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier:	NCT01012830 History of Changes
Other Study ID Numbers:	636-631
First Posted:	November 13, 2009
Last Update Posted:	November 13, 2009
Last Verified:	November 2009

Keywords provided by VA Nebraska Western Iowa Health Care System:

Schizophrenia; Cognitive Disorders; Dementia; Huperzine A; HupA

Additional relevant MeSH terms:

Schizophrenia; Dementia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Huperzine A	Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents