Mild Cognitive Impairment
Conditions
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.
Interventions
DRUG1612 capsule
Subjects will be assigned 1612 capsule,3 capsules per time(0.38g per capsule), 3 times per day.1612 capsule is a Chinse herbal medicine,which can tonification of spleen and kidney, mainly contains shudihuang(Rehmannia glutinosa),shanyao(Dioscorea opposita),shichangpu(Uncaria rhynchophylla)and so on,
DRUGPlacebos
Subjects will be assigned placebo identified to 1612 capsule,3 capsules per time, 3 times per day
Sponsors
Dongzhimen Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients should be enrolled if they met the following criteria\[14\]: 1. cognitive complaints from the patients or their families; 2. 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); 3. normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30); 4. 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; 5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5; 6. absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-IV criteria, 7. enough vision and hearing to accomplishment neuropsychological test; 8. capability to read words and write simple sentence; 9. capability and willingness to give informed consent and to comply with the study procedures.
Exclusion criteria
The patients would be ineligible if they had the following conditions: 1. non amnestic Mild cognitive impairment; 2. meeting the diagnostic criteria for dementia; 3. 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 4. 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; 5. 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; 6. used cholinesterase inhibitors or memantine within 1 month; 7. history of hypersensitivity to the treatment drugs; 8. concomitant drugs with the potential to interfere with cognition; 9. administration of other investigational drugs; severe impairment of the functions of the kidney or liver; 10. vegetarians or contraindications for animal innards.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed