Trial record 7 of 9 for:    HUPERZINE A

Huperzine A in Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborators:
Alzheimer's Disease Cooperative Study (ADCS)
Neuro-Hitech
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00083590
First received: May 26, 2004
Last updated: February 19, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: Huperzine A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Placebo-Controlled Therapeutic Trial to Determine Whether Natural Huperzine A Improves Cognitive Function

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 150
Study Start Date: April 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

The selection process is designed to allow enrollment of all people with AD who are likely to be testable at the conclusion of the study period, and who do not have concurrent medical conditions or medications that might influence cognitive testing or that would increase the risk of treatment. Women and members of minority groups are encouraged to volunteer.

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083590

  Show 29 Study Locations
Sponsors and Collaborators
Alzheimer's Disease Cooperative Study (ADCS)
Neuro-Hitech
Investigators
Principal Investigator: Paul S. Aisen, MD Georgetown University Medical Center, Memory Disorders Program
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00083590     History of Changes
Other Study ID Numbers: IA0052, ADC-023, IND 63,997
Study First Received: May 26, 2004
Last Updated: February 19, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease
Cholinesterase inhibitor

Additional relevant MeSH terms:
Huperzine A
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014