Clinical trial NCT01451749
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Sponsor: North China Pharmaceutical Group Corporation
Start date: 2008-09-01; Completion date: 2010-05-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Shenwu Capsule:1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.

Placebo: Placebo identical to donepezil tablets,1 placebo tablet/time, 1 time/day for 6 months. arm 2: Donepezil: 1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.

Placebo: Placebo identical to shenwu capsules,5 placebo capsules/time,3 times/day for 6 months
Interventions: intervention 1: Shenwu Capsule intervention 2: Donepezil
Intervention descriptions: intervention 1: 1 shenwu capsule contains 451 mg extract from herbs.5 capsules/time, 3 times/day for 6 months.

Placebo identified to donepezil: 1 tablet per time, 1 time per day for 6 months. intervention 2: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.

Placebo identical to shenwu capsules,5 capsules/time,3times/day for 6months.

Protocol documents: