Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment

NCT ID: NCT02982642

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1612 capsule

Subjects will take 1612 capsule 3 capsules per time(0.38g per capsule), 3 times per day for 52 weeks

Group Type: EXPERIMENTAL

1612 capsule

Intervention Type: DRUG

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,

Placebos

Subjects will take palcebo identified to 1612 capsule 3 capsules per time, 3 times per day for 52 weeks

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Subjects will be assigned placebo identified to 1612 capsule,3 capsules per time, 3 times per day

Interventions

1612 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,

Intervention Type: DRUG

Placebos

Subjects will be assigned placebo identified to 1612 capsule,3 capsules per time, 3 times per day

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Jinzhou Tian

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinzhou Tian, M.D,PhD

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Z20055424

Identifier Type: -

Identifier Source: org_study_id