Study Results
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Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2004-04-30
2007-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Huperzine A
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
ALL
No
Sponsors
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Alzheimer's Disease Cooperative Study (ADCS)
OTHER
Neuro-Hitech
INDUSTRY
National Institute on Aging (NIA)
NIH
Principal Investigators
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Paul S. Aisen, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University Medical Center, Memory Disorders Program
Locations
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University of Alabama
Birmingham, Alabama, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California, San Diego, Alzheimer's Disease Research Center
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
Georgetown University Medical Center, Memory Disorders Program
Washington D.C., District of Columbia, United States
Howard University School of Medicine
Washington D.C., District of Columbia, United States
MD Clinical
Fort Lauderdale, Florida, United States
Roskamp Institute Memory Clinic
Tampa, Florida, United States
University of South Florida, Suncoast Alzheimer's and Gerontology Center
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush Alzheimer's Disease Center, Rush University Medical Center
Chicago, Illinois, United States
ICPS Group
Boston, Massachusetts, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Alzheimer's Research Corporation
Paterson, New Jersey, United States
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, United States
Albany Medical Center
Albany, New York, United States
New York University Medical Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
North Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Vermont College of Medicine
Burlington, Vermont, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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ADC-023
Identifier Type: -
Identifier Source: secondary_id
IND 63,997
Identifier Type: -
Identifier Source: secondary_id
IA0052
Identifier Type: -
Identifier Source: org_study_id
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