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AzTrials

Alzheimer DiseasePhase 2NCT00083590

Huperzine A in Alzheimer's Disease

A Phase 2 study testing Huperzine A in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study will evaluate the safety and efficacy of the Chinese herb huperzine A in the treatment of Alzheimer's disease (AD) in a randomized controlled trial of its effect on cognitive function. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Huperzine A
How many people
150 participants
Where
29 sitesUnited States
Study dates
Apr 2004to Nov 2007
Phase
Phase 2
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NINDS/ADRDA criteria for probable AD.
  • Mini Mental State Examination between 10 and 24, inclusive.
  • Stable medical condition for 3 months prior to screening.
  • Supervision available for administration of study medications.
  • Study partner to accompany participant to all scheduled visits.
  • Fluent in English or Spanish.
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  • Age 55 years or older.
  • Modified Hachinski score equal to or less than 4.
  • CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion.
  • Able to complete baseline assessments.
  • 6 years of education, or work history sufficient to exclude mental retardation.
  • Able to ingest oral medication.
  • Stable doses of medications for 4 weeks prior to screening.
  • Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.

Who cannot join

  • History of active peptic ulcer disease within 1 year of screening.
  • Clinically significant cardiac arrhythmia.
  • Resting pulse less than 50.
  • Active neoplastic (cancer) disease (skin tumors other than melanoma are not excluded; participants with stable prostate cancer may be included at the discretion of the Project Director).
  • Use of another investigational agent within 2 months of screening.
  • History of clinically significant stroke.
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  • Current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injury, or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
  • Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol.
  • Residence in a skilled nursing facility; but patients in an assisted living facility are acceptable.
  • Excluded Medications:
  • Use of cholinesterase inhibitors (galantamine, rivastigmine, donepezil, and tacrine) within 2 months of screening.
  • Regular use of narcotic analgesics (>2 doses per week) within 4 weeks of screening.
  • Use of medications with significant central nervous system anticholinergic activity within 2 months of screening (e.g. tricyclic antidepressants, diphenhydramine).
  • Use of anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline) within 2 months of screening.
  • Participation in any other investigational drug study within 2 months of screening (individuals may not participate in any other drug study while participating in this protocol).
  • Use of estrogen is allowed if the dose has been stable for 3 months prior to screening.
  • Use of vitamin E is allowed if the dose has been stable for 3 months prior to screening.
  • Use of memantine is allowed if the dose has been stable for 3 months prior to screening.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Emory University

    Atlanta, Georgia, 30329

  • University of Alabama

    Birmingham, Alabama, 35294

  • ICPS Group

    Boston, Massachusetts, 02131

  • University of Vermont College of Medicine

    Burlington, Vermont, 05401

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Rush Alzheimer's Disease Center, Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • MD Clinical

    Fort Lauderdale, Florida, 33321

  • University of California, Irvine

    Irvine, California, 92697

  • University of California, San Diego, Alzheimer's Disease Research Center

    La Jolla, California, 92037

  • University of Nevada School of Medicine

    Las Vegas, Nevada, 89102

  • University of Southern California

    Los Angeles, California, 90033

  • New York University Medical Center

    New York, New York, 10016

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Medical University of South Carolina

    North Charleston, South Carolina, 29406

  • Nathan S. Kline Institute for Psychiatric Research

    Orangeburg, New York, 10962

  • Alzheimer's Research Corporation

    Paterson, New Jersey, 08759

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • University of Medicine and Dentistry of New Jersey

    Piscataway, New Jersey, 08855

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97201

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • University of California, Davis

    Sacramento, California, 95817

  • Roskamp Institute Memory Clinic

    Tampa, Florida, 33617

  • University of South Florida, Suncoast Alzheimer's and Gerontology Center

    Tampa, Florida, 33617

  • Georgetown University Medical Center, Memory Disorders Program

    Washington D.C., District of Columbia, 20057

  • Howard University School of Medicine

    Washington D.C., District of Columbia, 20060

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Multi-Center, Double-Blind, Placebo-Controlled Therapeutic Trial to Determine Whether Natural Huperzine A Improves Cognitive Function

The present study will evaluate the safety and efficacy of the Chinese herb huperzine A in the treatment of Alzheimer's disease (AD) in a randomized controlled trial of its effect on cognitive function.

Read the detailed description

Huperzine A is a natural cholinesterase inhibitor derived from the Chinese herb Huperzia serrata. There is evidence that huperzine A may compare favorably in symptomatic efficacy to cholinesterase inhibitors currently in use. In addition, huperzine A has antioxidant and neuroprotective properties that suggest that it may be useful as a disease-modifying treatment for Alzheimer's disease (AD). The drug is currently available as a nutraceutical in this country, and is being used by some U.S. clinicians to treat AD. However, there have been no controlled clinical trials outside China assessing its toxicity and efficacy. The present study will evaluate huperzine A in the treatment of AD in a randomized controlled trial of its effect on cognitive function.

The primary aim of this multicenter, double-blind, placebo-controlled therapeutic Phase II trial is to determine whether treatment with huperzine A 200µg twice a day improves cognitive function in individuals with AD. Secondary aims of this study are to: a) determine whether treatment with huperzine A 400µg twice a day improves cognitive function in individuals with AD; b) determine the effect of huperzine A treatment on global clinical status, activities of daily living, and behavior in AD; c) evaluate the tolerability of huperzine A treatment at dosages of 200µg twice a day and 400µg twice a day in AD; and d) determine the relationship between blood cholinesterase activity and cognitive function in individuals with AD treated with huperzine A. A total of 150 participants will be randomly assigned to three groups of equal size. This will allow a comparison of huperzine A 200µg twice a day, huperzine A 400µg twice a day, and placebo. The primary outcome measures will be the change in score on the ADAScog at the 16 week visit. Secondary outcome measures include the ADCS clinical global impression of change (CGIC) (Schneider et al 1997) and activities of daily living (ADL) (Galasko et al 1997) scales, and the Neuropsychiatric Inventory (Cummings 1997). Volunteers must be able to participate in the study for 24 weeks and make 9 visits to the trial site.

At the end of the double-blind study, participants will be invited to continue huperzine A treatment for 6 months in an open-label extension phase. Participants will receive 200µg of huperzine A twice a day for six consecutive months, and will be assessed at 3-month intervals (months 6, 9, and 12, with month 6 assessments coinciding with the final visit of the double-blind phase).

Being tested
Huperzine A
Keywords
Alzheimer disease, Cholinesterase inhibitor
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Huperzine ADrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083590
Sponsor's protocol ID
IA0052
Other IDs
ADC-023, IND 63,997
Status last verified
Feb 2008
First submitted
26 May 2004
Last updated
21 Feb 2008
Results posted
No

Publications

  • Bai DL, Tang XC, He XC. Huperzine A, a potential therapeutic agent for treatment of Alzheimer's disease. Curr Med Chem. 2000 Mar;7(3):355-74. doi: 10.2174/0929867003375281.

    PubMed 10637369

  • Ved HS, Koenig ML, Dave JR, Doctor BP. Huperzine A, a potential therapeutic agent for dementia, reduces neuronal cell death caused by glutamate. Neuroreport. 1997 Mar 3;8(4):963-8. doi: 10.1097/00001756-199703030-00029.

    PubMed 9141073

  • Mazurek A: An open-label trial of huperzine A in the treatment of Alzheimer's disease. Alternative Therapies 5(2): 97-98, March 16, 2000.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Huperzine A in people with Alzheimer Disease, run by National Institute on Aging (NIA) at 29 sites 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 14 inclusion and 18 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: finished, as of the sponsor's last update on 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083590, which also lists 3 linked publications.

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 21 Feb 2008.

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