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Cognitive DysfunctionPhase 1/2NCT03601000

Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment

A Phase 1/2 study testing Yi-Zhi-An-Shen in people with Cognitive Dysfunction, run by Chengdu University of Traditional Chinese Medicine at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to investigate the safety and efficacy of Yi-Zhi-An-Shen Granules in participants with amnestic mild cognitive impairment (aMCI). Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Dysfunction
What is being tested?
Yi-Zhi-An-Shen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesChina
Study dates
21 Apr 2018to 12 Sep 2019
Phase
Phase 1/2
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 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject has assigned informed consent to participate in the study and continues to give willing consent for participation
  • Age from 60 to 85 years with a diagnosis of aMCI
  • Educational level of at least 6 years
  • Availability of a "study partner" who can assist in completing rating scales for the duration of the study
  • Cognitive complaints reported by the subject and confirmed by the "study partner"
  • Clinical Dementia Rating (CDR) global score of 0.5, and memory item score of 0.5
  • Mini-mental state examination (MMSE) score of 24-30
  • Diagnostic and Statistical Manual of Mental Disorders, Version 5 (DSM-V) criteria of dementia not fulfilled

Who cannot join

  • Has been previously enrolled in this study and received the investigational product
  • Has received an investigational product within 30 days prior to screening
  • Has received disease-modifying therapy
  • Has a known allergy to the study drug or any of its constituents
  • Has a history of alcohol abuse or alcohol dependency in the 3 years prior to study entry, or is an alcoholic or drug addict, as determined by the investigator
  • Has ongoing clinically significant (as judged by the investigator), metabolic or any other disease that could currently cause impaired memory (e.g., untreated thyroid disease, vitamin or other nutritional deficiencies, chronic kidney, or liver disease)
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  • Memory impairment that can be attributed to a disease or condition other than an early phase neurodegenerative syndrome
  • Has a parkinsonian movement disorder
  • Use of psychoactive medications that would affect the subject's ability to reliably perform neurocognitive testing or create uncertainty in distinguishing between the effects of the psychoactive medication and the subject's underlying cognitive impairment (e.g., benzodiazepines, sedatives, antipsychotics)
  • History of major recurrent depressive disorder (DSM-V) within the last 5 years prior to screening
  • Has a brain tumor or other intracranial lesion, a disturbance of cerebral spinal fluid circulation (e.g., normal pressure hydrocephalus), and/or a significant history of head trauma or brain surgery
  • Has signs of major cerebrovascular disease, with score of modified Hachinski Ischemia Score (mHIS) at more than 4, or as verified by medical history and/or brain MRI or CT
  • Has severe visual or hearing impairments that cannot cooperate with examinations
  • Has severe digestive system diseases
  • Has received antibiotics within 60 days prior to screening

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Teaching Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610075

  • Welfare Institution of Emei Civil Administration

    Leshan, Sichuan

Other trials in China

About this study

Official title: Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Study

The main purpose of this study is to investigate the safety and efficacy of Yi-Zhi-An-Shen Granules in participants with amnestic mild cognitive impairment (aMCI).

Read the detailed description

The investigators performed a randomized, placebo-controlled, double-blind study on evaluating effect of Yi-Zhi-An-Shen Granules on cognition, sleep quality, and gut microbiome of older adults with amnestic mild cognitive impairment (aMCI). The investigators plan to involve 80 cases for observation in 2 years (40 cases for each group), expecting that cognition and sleep quality of aMCI patients can be improved by Yi-Zhi-An-Shen Granules versus placebo, and discussing the differences between individuals with aMCI and ones with normal cognition, also investigating whether this Chinese medicine compound can regulate gut microbiome of older individuals with aMCI.

Being tested
Yi-Zhi-An-Shen, Placebo
Keywords
amnestic
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yi-Zhi-An-ShenDrug

    Yi-Zhi-An-Shen Granules 5g given three times a day for up to 16 weeks.

  • PlaceboDrug

    Placebo granules 5g given three times a day for up to 16 weeks.

Study groups in NCT03601000
Study groupRoleWhat they receive
Yi-Zhi-An-ShenExperimentalYi-Zhi-An-Shen Granules given three times every day for 16 weeks.
Receives: Drug: Yi-Zhi-An-Shen
PlaceboPlacebo comparatorPlacebo given three times every day for 16 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Alzheimer´s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score

    The ADAS-Cog was developed as an outcome measure for global cognition in clinical trials. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation, for a total of 70 points (0: no cognitive impairment; 70: severe impairment). An improvement of 4 points is used as a criterion of clinically effective anti-dementia drugs.

    Measured: Baseline, 16 weeks, 22 months

Secondary outcomes (6)

  1. Change from Baseline in the Mini Mental Status Examination (MMSE)

    Changes in the global cognitive function will be accessed by MMSE to evaluate the severity of subjects' cognitive impairment. The MMSE includes orientation, registration, attention and calculation, recalling and language tests, for a total of 30 points. A score below 24 is considered abnormal for dementia screening.

    Measured: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

  2. Change from Baseline in the Montreal Cognitive Assessment (MoCA)

    MoCA (Changsha Version), as a assessment tool for rapid MCI screening, will be used to assess changes in the global cognitive function. With a total of 30 points, a score below 25 is considered abnormal, and the lower score indicates the worse cognition.

    Measured: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

  3. Change from Baseline in the Clinical Dementia Rating Scale (CDR)

    The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD and related dementias: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. Scores on the CDR range from 0 (no impairment) to 3 (severe impairment). The total CDR ratings for each of the six cognitive/functional domains can be added to create a CDR sum of boxes (CDR-SB).

    Measured: Baseline, 16 weeks, 22 months

  4. Change from Baseline in the Activity of Daily Living (ADL)

    ADLs will be assessed including basic activities of daily living (BADL) and instrumental activities of daily living (IADL). An individual's BADL will be evaluated mainly by the subjects' performance from the perspectives of bathing, dressing, grooming, initiation, toileting and feeding, with six items and a sum of scores ranging from 0 (normal) to 24 (complete dependence on others). And modified Lawton Instrumental Activities of Daily Living Scale will be used to measure the IADL of a subject, with eight items and a sum of scores ranging from 0 (normal) to 32 (complete dependence on others).

    Measured: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

  5. Change from Baseline in the Pittsburgh sleep quality index (PSQI)

    The PSQI will be used to assess participants' comprehensive sleep quality, including sleep quality, sleep duration, sleep efficiency, sleep disorders, daytime dysfunction, sleeping aids, etc. The total score is 21, with a higher score indicating a worse sleep quality.

    Measured: Baseline, 8 weeks, 16 weeks, 10 months, 16 months, 22 months

  6. Differences between patients with aMCI and individuals with normal cognition in gut microbiome.

    The investigators will collect some fecal samples from participants. Then, differences in gut microbiome between patients with aMCI and individuals with normal cognition will be analyzed using 16SrDNA and Metagenomics analyses. When it is available, the investigators will also assess the change in gut microbiome between the treatment group and the placebo group after the intervention of YZASG.

    Measured: Baseline, 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start21 Apr 2018
  3. Primary completion30 Apr 2019
  4. Study completion12 Sep 2019

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, double-blind, placebo-controlled study.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03601000
Sponsor's protocol ID
ChengduUTCM-WWB-201801
Status last verified
Sep 2019
First submitted
5 Apr 2018
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Miao YC, Tian JZ, Shi J, Mao M. Effects of Chinese medicine for tonifying the kidney and resolving phlegm and blood stasis in treating patients with amnestic mild cognitive impairment: a randomized, double-blind and parallel-controlled trial. Zhong Xi Yi Jie He Xue Bao. 2012 Apr;10(4):390-7. doi: 10.3736/jcim20120407.

    PubMed 22500712

  • Yue S, He T, Li B, Qu Y, Peng H, Chen J, Lei M, Chen C, Wu W. Effectiveness of Yi-Zhi-An-Shen granules on cognition and sleep quality in older adults with amnestic mild cognitive impairment: protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2019 Aug 20;20(1):518. doi: 10.1186/s13063-019-3607-x.

    PubMed 31429790

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Yi-Zhi-An-Shen in people with Cognitive Dysfunction, run by Chengdu University of Traditional Chinese Medicine at 2 sites 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 from Baseline in Alzheimer´s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Score (time frame: Baseline, 16 weeks, 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03601000, which also lists 2 linked publications.

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 19 Sep 2019.

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