Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment

Dongzhimen Hospital, Beijing

Status and phase

Withdrawn

Phase 4

Conditions

Mild Cognitive Impairment

Treatments

Drug: Placebos

Drug: 1612 capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT02982642

Z20055424

Details and patient eligibility

About

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.

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.