Xel Pharmaceuticals Announces Successful Completion of Prototype Once-A-Week Huperzine A Transdermal Patch for Alzheimer’s Disease

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Xel Pharmaceuticals, Inc. announced today the completion of the development of its once-a-week Huperzine A transdermal patch for the treatment of Alzheimer’s Disease (AD). The prototype transdermal patch can deliver 400–800 mcg of Huperzine A per day for up to seven days.

This is a prototype and is not currently available for purchase.

Huperzine A Factsheet (Alzheimer’s)

Note: the clinical trial of Huperzine A is closed but here is the link to the trial information..Huperzine A in Alzheimer’s Disease-The Clinical Trial

Xel Pharmaceuticals Announces Successful Completion of Prototype Once-A-Week Huperzine A Transdermal Patch for Alzheimer’s Disease

Xel Pharmaceuticals, Inc. announced today the completion of the development of its once-a-week Huperzine A transdermal patch for the treatment of Alzheimer’s Disease (AD). The prototype transdermal patch can deliver 400–800 mcg of Huperzine A per day for up to seven days. Huperzine A is a naturally occurring alkaloid found from the club moss Huperzia serrata that has been used for decades in China as a prescription medication for the treatment of dementia. Huperzine A is a potent, highly selective and reversible inhibitor of acetyl cholinesterase. Additionally, Huperzine A has anti-oxidative properties and possesses neuro-protective properties against glutamate that induce neuronal toxicity at the N-methyl-D-aspartate (NMDA) receptor.

Dr. Danyi Quan, Chief Scientific Officer of Xel, said, “The failure of recent Phase III clinical trials for AD treatment may cast some new doubt on that theory as well as on other experimental drugs. In addition, some new Alzheimer drugs show potential risks including serious side effects. However, the clinical studies performed in China to-date showed Huperzine A to be more effective than other cholinesterase inhibitors currently on the market, and the US clinical Phase II trials with Huperzine A oral tablets conducted by the nation’s leader in AD therapy, Dr. Paul Aisen, clearly demonstrated the efficacy and safety of Huperzine A in the treatment of patients with AD.”

“In the past 10 years, there have been limits and some real difficulties in finding a good candidate from existing western medicines to develop transdermal drug delivery systems. However, many drug candidates derived from botanic sources with proven safety and efficacy data are available for further development, which now has become a fast and effective way for us to select candidates for designing our advanced drug delivery systems. Huperzine A is one of our most promising and successful transdermal products. Its low therapeutic dose and molecular weight makes Huperzine A ideal for transdermal drug delivery. Our once-a-week transdermal patch is a clearly preferable treatment method to AD patients and caregivers. The prototype Huperzine A transdermal patch is ready for IND filing and further development.” Dr. Quan added.

According to Mr. Wade Xiong, President and CEO of Xel, “We are delighted to announce the completion of the development of our prototype Huperzine A transdermal patch. Xel has two world renowned scientists, Dr. Dinesh C. Patel and Dr. Danyi Quan, both of whom pioneer in transdermal delivery technology. As our Chairman of the Board, Dr. Patel also was the past founder of transdermal drug delivery pioneer TheraTech, Inc. (now Watson Pharmaceuticals). Xel’s business strategy is to identify compounds having proven safety and efficacy, and to further develop advanced drug delivery systems in order to provide better delivery profiles as well as patent protection. Currently, Xel has several co-development and licensing opportunities available for major pharmaceutical companies.”

 

Huperzine A in Alzheimer’s Disease-The Clinical Trial

The Huperzine A in Alzheimer’s Disease clinical trial is currently open and recruiting patients. This is a Phase II clinical trial.

Huperzine A in Alzheimer’s Disease-The Clinical Trial

See the trial specification at Clinical Trials.gov

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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 above, Genders Eligible for Study: Both CriteriaThe 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.

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