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

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ClinicalTrials.gov Identifier: NCT01012830
Recruitment Status : Unknown
Verified November 2009 by VA Nebraska Western Iowa Health Care System.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2009
Last Update Posted : November 13, 2009
Sponsor:
Collaborator:
American Legion of Iowa Foundation
Information provided by:
VA Nebraska Western Iowa Health Care System

Study Description
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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
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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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Information from the National Library of Medicine

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012830


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

Locations
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United States, Nebraska
Veterans Affairs Nebraska Western Iowa Health Care System
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
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Principal Investigator: Prasad R Padala, MD, MS VA Office of Research and Development
More Information
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Responsible Party: Prasad R. Padala, M.D., VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier: NCT01012830    
Other Study ID Numbers: 636-631
First Posted: November 13, 2009    Key Record Dates
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:
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Dementia
Schizophrenia
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