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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01012830
Other study ID # 636-631
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received November 12, 2009
Last updated November 12, 2009
Start date December 2009
Est. completion date April 2011

Study information

Verified date November 2009
Source VA Nebraska Western Iowa Health Care System
Contact Daniel A Ramirez, BS
Phone 800-451-5796
Email Daniel.Ramirez@va.gov
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date April 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 59 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Veterans Affairs Nebraska Western Iowa Health Care System Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
VA Nebraska Western Iowa Health Care System American Legion of Iowa Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary MATRICS Consensus Cognitive Battery First visit, 4 weeks, 8 weeks No
Secondary University of California Performance Skills Assessment-Brief (UPSA-B) First visit, 8 weeks No
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