Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083590
Status:
COMPLETED
Last Update Posted:
2008-02-21
First Post:
2004-05-26
Brief Title:
Huperzine A in Alzheimers Disease
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Multi-Center Double-Blind Placebo-Controlled Therapeutic Trial to Determine Whether Natural Huperzine A Improves Cognitive Function
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study will evaluate the safety and efficacy of the Chinese herb huperzine A in the treatment of Alzheimers disease AD in a randomized controlled trial of its effect on cognitive function
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 Alzheimers disease AD The drug is currently available as a nutraceutical in this country and is being used by some US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 63997 | None | None | None |
| ADC-023 | None | None | None |