SchizophreniaPhase 4NCT01012830
Huperzine-A to Help With Mental Problems and the Inability to Care for Onself in Patients With Schizophrenia
A Phase 4 study testing Huperzine A in people with Schizophrenia and Dementia, run by VA Nebraska Western Iowa Health Care System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 59 years
- Conditions the study is for
- Schizophrenia, Dementia
- What is being tested?
- Huperzine A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- minimal depression (Calgary <10)
- stable dose of other psychotropics (2 months)
- not pregnant.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Nebraska Western Iowa Health Care System
Omaha, Nebraska, 68105
Daniel A Ramirez, BS, 800-451-5796 ext. 4036, Daniel.Ramirez@va.gov
Prasad R Padala, MD, MS
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Dementia
- Being tested
- Huperzine A
- Keywords
- Schizophrenia, Cognitive Disorders, Dementia, Huperzine A, HupA
- Medical subject headings
- Schizophrenia, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine ADrug
Also called HupA, Huperzine-A, Huperzia serrata
Huperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Huperzine A | Experimental | 200 micrograms (mcg) of HuperzineA taken twice daily. Receives: Drug: Huperzine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
MATRICS Consensus Cognitive Battery
Measured: First visit, 4 weeks, 8 weeks
Secondary outcomes (1)
University of California Performance Skills Assessment-Brief (UPSA-B)
Measured: First visit, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Nebraska Western Iowa Health Care System
- Sponsor type
- US federal agency
- Collaborators
- American Legion of Iowa Foundation
- Investigators
- Prasad R Padala, MD, MS, Principal investigator, VA Office of Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012830
- Sponsor's protocol ID
- 636-631
- Status last verified
- Nov 2009
- First submitted
- 12 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huperzine-A for Cognitive Dysfunction and Functional Status in Schizophrenia
- ClinicalTrials.gov ID
- NCT01012830
- Acronym / sponsor ID
- 636-631
- Conditions
- Schizophrenia, Dementia
- Keywords
- Schizophrenia, Cognitive Disorders, Dementia, Huperzine A, HupA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- VA Nebraska Western Iowa Health Care SystemUS federal agency
- Collaborators
- American Legion of Iowa Foundation
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Huperzine A | Experimental | Drug: Huperzine A200 micrograms (mcg) of HuperzineA taken twice daily. |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huperzine AAlso: HupA, Huperzine-A, Huperzia serrataHuperzine A in 200 microgram (mcg) capsules taken twice daily for 8 weeks. | Drug | Huperzine A |
Primary outcome
MATRICS Consensus Cognitive Battery
Time frame: First visit, 4 weeks, 8 weeks
1 secondary outcome
University of California Performance Skills Assessment-Brief (UPSA-B)
Time frame: First visit, 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasad R Padala, MD, MS principal investigator
VA Office of Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huperzine A in people with Schizophrenia and Dementia, run by VA Nebraska Western Iowa Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel A Ramirez, BS (800-451-5796 ext. 4036, Daniel.Ramirez@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (time frame: First visit, 4 weeks, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2009.