Mild Cognitive ImpairmentPhase 4NCT02982642
Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment
A Phase 4 study testing 1612 capsule in people with Mild Cognitive Impairment, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- 1612 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen Hospital ,Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700
About this study
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.
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
- Being tested
- 1612 capsule, Placebos
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1612 capsuleDrug
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,
PlacebosDrug
Subjects will be assigned placebo identified to 1612 capsule,3 capsules per time, 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| 1612 capsule | Experimental | Subjects will take 1612 capsule 3 capsules per time(0.38g per capsule), 3 times per day for 52 weeks Receives: 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 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 52 weeks
Secondary outcomes (3)
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.
Measured: 52 weeks
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.
Measured: 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)
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Sponsor cannot conduct research due to insufficient funding supportment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinzhou Tian, Dongzhimen Hospital, Beijing
- Investigators
- Jinzhou Tian, M.D,PhD, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982642
- Sponsor's protocol ID
- Z20055424
- Status last verified
- Mar 2021
- First submitted
- 1 Dec 2016
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02982642
- Acronym / sponsor ID
- Z20055424
- Conditions
- Mild Cognitive Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor cannot conduct research due to insufficient funding supportment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1612 capsule | Experimental | Drug: 1612 capsuleSubjects will take 1612 capsule 3 capsules per time(0.38g per capsule), 3 times per day for 52 weeks |
| Placebos | Placebo comparator | Drug: PlacebosSubjects will take palcebo identified to 1612 capsule 3 capsules per time, 3 times per day for 52 weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1612 capsuleSubjects 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, | Drug | 1612 capsule |
| PlacebosSubjects will be assigned placebo identified to 1612 capsule,3 capsules per time, 3 times per day | Drug | Placebos |
Primary outcome
Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change from baseline to end of double-blind treatment of Mini-Mental State Examination(MMSE)
Time frame: 52 weeks
Change from baseline to end of double-blind treatment of Delayed Story Recall test (DSR)
Time frame: 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)
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinzhou Tian, M.D,PhD principal investigator
Dongzhimen Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1612 capsule in people with Mild Cognitive Impairment, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive scores: Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog) (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.