Mild Cognitive Impairment Clinical Trial
Official title:
Phase III Study of Shenwu Capsule in Treating Amnestic Mild Cognitive Impairment
The purpose of this phase III study is to further evaluate the effects of shenwu capsule, a traditional Chinese herbal medicine, on cognition, function and memory in patients with amnestic mild cognitive impairment (MCI) who are at greater risk for developing Alzheimer's disease, in a 6-month supervised protocol of a traditional Chinese herbal medicine. The results of this study may provide support for a relatively simple and inexpensive treatment strategy with herbal therapy that specifically targets individuals with the mild cognitive impairment that directly influence risk of developing dementia for older adults.
Mild cognitive impairment (MCI) refers to a group of individuals who have some cognitive
impairment but of insufficient severity to constitute dementia1,which is a transitional
stage between normal aging and dementia. Amnestic MCI is the most common subtype of MCI,
which shows the least reversion to normal, and is defined as a significant impairment in
memory but with no impairment in activities of daily living. In an interventional study of
patients meeting Petersen criteria for amnestic MCI, 16% progressed to dementia per year,
99% of whom received an AD diagnosis. Hence, MCI, in particular amnestic MCI is generally
recognized in many cases to represent prodromal AD and becomes a new target for prevention
and treatment of AD.
The specific aims for the study is to evaluate change in Efficacy and safety of shenwu
capsule in treating amnestic MCI. Using a randomized controlled parallel group design, 324
older adults diagnosed with amnestic MCI participate in a 6-month supervised protocol of
either shenwu capsule or donepezil. Cognitive testing and blood collection will occur at
baseline, and months 3 and 6. Before the 6-month intervention, medial temporal atrophy (MTA)
or hippocampal volume atrophy on the CT or MRI scan are assessed for all subjects. The
results of this study may provide support for a safer and inexpensive treatment strategy
that specifically targets individuals with the mild cognitive impairment that directly
influence risk of developing dementia for older adults.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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