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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by VA Nebraska Western Iowa Health Care System. Recruitment status was Not yet recruiting

First Received on November 12, 2009. No Changes Posted

Sponsor:	VA Nebraska Western Iowa Health Care System
Collaborator:	American Legion of Iowa Foundation
Information provided by:	VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier:	NCT01012830

Purpose

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	Intervention	Phase
Schizophrenia Dementia	Drug: Huperzine A	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Dementia Schizophrenia

Drug Information available for: Huperzine

U.S. FDA Resources

Further study details as provided by VA Nebraska Western Iowa Health Care System:

Primary Outcome Measures:

MATRICS Consensus Cognitive Battery [ Time Frame: First visit, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

University of California Performance Skills Assessment-Brief (UPSA-B) [ Time Frame: First visit, 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	December 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	19 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 19-59
diagnosis of schizophrenia by MINI
cognition score 1 standard deviation below published norms in controls
clinically stable for 12 weeks i.e. on the same antipsychotic(s) for 8 weeks and stable dose for at least 4 weeks
have no more than moderate severity rating on hallucinations, delusions formal thought disorder (BPRS), negative symptoms (PANSS_N)
minimal EPS (Simpson-Angus <6)
minimal depression (Calgary <10)
stable dose of other psychotropics (2 months)
not pregnant.

Exclusion Criteria:

history of active peptic ulcer disease within 1 year of screening
clinically significant cardiac arrhythmia
resting pulse less than 50
active cancer (skin tumors other than melanoma are not excluded)
history of clinically significant stroke
current evidence or history in the past 2 years of epilepsy, focal brain lesion
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012830

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

Department of Veterans Affairs

More Information

No publications provided

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
Study First Received:	November 12, 2009
Last Updated:	November 12, 2009
Health Authority:	United States: Federal Government

Keywords provided by VA Nebraska Western Iowa Health Care System:

Schizophrenia
Cognitive Disorders
Dementia
Huperzine A
HupA

Additional relevant MeSH terms:

Dementia
Schizophrenia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Huperzine A
Neuroprotective Agents

Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012