Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Drug: 1612 capsuleDrug: Placebos
- Registration Number
- NCT02982642
- Lead Sponsor
- Dongzhimen Hospital, Beijing
- Brief Summary
This study is a 52-weeks, multicenter, randomized, double-blind, placebo controlled, parallel trial which will be carried out in 15 centers around China. The study population includes amnestic mild cognitive impairment patients (planned a total of 240) aged 55-85 in both gender. Participants will be randomly allocated to 1612 capsules (1.14g per time, 3 times per day) or placebo for a 52-weeks double-blind treatment period. The primary outcome measure is change from baseline in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental State Examination (MMSE), Delayed Story Recall test (DSR), Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is being assessed by observing side effects and adverse reaction during the entire treatment period. Statistical analysis will be conducted according to per-protocol population and intend-to-treat population and the safety will be analyzed in safety set.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Patients should be enrolled if they met the following criteria[14]:
- cognitive complaints from the patients or their families;
- objective evidence for memory impairment, delayed story recall test(DSR)<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10);
- normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30);
- preservation of activities of daily living, with Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score between 38 and 52;
- cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5;
- absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-IV criteria,
- enough vision and hearing to accomplishment neuropsychological test;
- capability to read words and write simple sentence;
- capability and willingness to give informed consent and to comply with the study procedures.
The patients would be ineligible if they had the following conditions:
- non amnestic Mild cognitive impairment;
- meeting the diagnostic criteria for dementia;
- cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a brain tumor ,or drug abuse or alcohol abuse
- having significant psychiatric disease, depression, the Hamilton depression scale >12; CT or MRI scan showed central nervous system infections Infarction or focal lesions within 12 months，the Hachinski Ischemic Scale (HIS)>4;
- combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD; severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer;
- used cholinesterase inhibitors or memantine within 1 month;
- history of hypersensitivity to the treatment drugs;
- concomitant drugs with the potential to interfere with cognition;
- administration of other investigational drugs; severe impairment of the functions of the kidney or liver;
- vegetarians or contraindications for animal innards.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1612 capsule 1612 capsule Subjects will take 1612 capsule 3 capsules per time(0.38g per capsule), 3 times per day for 52 weeks Placebos Placebos Subjects will take palcebo identified to 1612 capsule 3 capsules per time, 3 times per day for 52 weeks
- Primary Outcome Measures
Name Time Method Change from baseline to end of double-blind treatment of rate of dementia conversion from mild cognitive impairment 52 weeks The rate of demention conversion will accessed from baselin at week 0 and week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog) 52 weeks Cognition will accessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), at baseline (day 1 clinic visit) and week 4, week 12, week 24 ,week 36 , week 48 and week 52.
- Secondary Outcome Measures
Name Time Method Change from baseline to end of double-blind treatment of Mini-Mental State Examination(MMSE) 52 weeks Cognition will accessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), at baseline (day 1 clinic visit) and week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR) 52 weeks Memory will accessed with the delayed story recall test(DSR), at baseline (day 1 clinic visit) and week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Change from baseline to end of double-blind treatment of Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) 52 weeks Ability of daily living will accessed with the Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24), at baseline (day 1 clinic visit) and week 4, week 12, week 24 ,week 36 , week 48 and week 52.
Trial Locations
- Locations (1)
Dongzhimen Hospital ,Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China