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Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status

Withdrawn

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

1612 capsule

Placebos

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1612 capsule

Placebos

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)

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

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 Outcome Measures

Change from baseline to end of double-blind treatment of Mini-Mental State Examination(MMSE)

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)

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)

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.

Full Information

NCT ID

NCT02982642

First Posted

December 1, 2016

Last Updated

March 2, 2021

Sponsor

Dongzhimen Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT02982642

Brief Title

Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment

Official Title

The Safety and Efficacy of 1612 Capsules in Treatment of aMnestic Mild Cognitive Impairment: a 52-week, Double Blind,Randomized, Parallel,Placebo Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor cannot conduct research due to insufficient funding supportment

Study Start Date

January 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dongzhimen Hospital, Beijing

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1612 capsule

Arm Type

Experimental

Arm Description

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

Arm Title

Placebos

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

1612 capsule

Intervention Description

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

Intervention Name(s)

Placebos

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)

Description

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.

Time Frame

52 weeks

Title

Change from baseline to end of double-blind treatment of rate of dementia conversion from mild cognitive impairment

Description

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.

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Change from baseline to end of double-blind treatment of Mini-Mental State Examination(MMSE)

Description

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.

Time Frame

52 weeks

Title

Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)

Description

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.

Time Frame

52 weeks

Title

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)

Description

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinzhou Tian, M.D,PhD

Organizational Affiliation

Dongzhimen Hospital, Beijing University of Chinese Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dongzhimen Hospital ,Beijing University of Chinese Medicine

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100700

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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