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

Primary Purpose

Schizophrenia, Dementia

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Huperzine A

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognitive Disorders, Dementia, Huperzine A, HupA

Eligibility Criteria

19 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Veterans Affairs Nebraska Western Iowa Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Huperzine A

Arm Description

200 micrograms (mcg) of HuperzineA taken twice daily.

Outcomes

Primary Outcome Measures

MATRICS Consensus Cognitive Battery

Secondary Outcome Measures

University of California Performance Skills Assessment-Brief (UPSA-B)

Full Information

NCT ID

NCT01012830

First Posted

November 12, 2009

Last Updated

November 12, 2009

Sponsor

VA Nebraska Western Iowa Health Care System

Collaborators

American Legion of Iowa Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01012830

Brief Title

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

Official Title

Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

VA Nebraska Western Iowa Health Care System

Collaborators

American Legion of Iowa Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Dementia

Keywords

Schizophrenia, Cognitive Disorders, Dementia, Huperzine A, HupA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Huperzine A

Arm Type

Experimental

Arm Description

200 micrograms (mcg) of HuperzineA taken twice daily.

Intervention Type

Drug

Intervention Name(s)

Huperzine A

Other Intervention Name(s)

HupA, Huperzine-A, Huperzia serrata

Intervention Description

Huperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks.

Primary Outcome Measure Information:

Title

MATRICS Consensus Cognitive Battery

Time Frame

First visit, 4 weeks, 8 weeks

Secondary Outcome Measure Information:

Title

University of California Performance Skills Assessment-Brief (UPSA-B)

Time Frame

First visit, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel A Ramirez, BS

Phone

800-451-5796

Ext

4036

Daniel.Ramirez@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prasad R Padala, MD, MS

Organizational Affiliation

VA Office of Research and Development

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veterans Affairs Nebraska Western Iowa Health Care System

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel A Ramirez, BS

Phone

800-451-5796

Ext

4036

Daniel.Ramirez@va.gov

First Name & Middle Initial & Last Name & Degree

Prasad R Padala, MD, MS

12. IPD Sharing Statement

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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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