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

Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Dementia
• Intervention / Treatment: Drug: Huperzine A

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Daniel A Ramirez, BS; Phone Number: 4036 800-451-5796; Email: Daniel.Ramirez@va.gov

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Veterans Affairs Nebraska Western Iowa Health Care System
      • Contact: Daniel A Ramirez, BS; Phone Number: 4036 800-451-5796; Email: Daniel.Ramirez@va.gov
      • Principal Investigator: Prasad R Padala, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MATRICS Consensus Cognitive Battery	First visit, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
University of California Performance Skills Assessment-Brief (UPSA-B)	First visit, 8 weeks

Collaborators and Investigators

• Sponsor: VA Nebraska Western Iowa Health Care System
• Collaborators: American Legion of Iowa Foundation
• Investigators: Principal Investigator: Prasad R Padala, MD, MS, VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: November 12, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimate): November 13, 2009

Study Record Updates

• Last Update Posted (Estimate): November 13, 2009
• Last Update Submitted That Met QC Criteria: November 12, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Schizophrenia; Dementia; Cognitive Disorders; Huperzine A; HupA
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Dementia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Cholinesterase Inhibitors; Huperzine A
• Other Study ID Numbers: 636-631