Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment

NCT02982642 | Withdrawn Phase 4 DMC

• 1 other identifier: Z20055424
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  52 weeks

• 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.

  52 weeks

Secondary Outcomes (3)

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

  52 weeks

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

  52 weeks

• 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

Study Arms (2)

1612 capsule

EXPERIMENTAL

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

Drug: 1612 capsule

Placebos

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

1612 capsule 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,

1612 capsule

Placebos DRUG

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

Placebos

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital ,Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100700, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jinzhou Tian, M.D,PhD

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)