Subjective Memory ImpairmentNCT03849391
Effect of Skate Skin Extract on Cognitive Function in Adults
A study testing Skate group in people with Subjective Memory Impairment, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Memory Impairment
- What is being tested?
- Skate group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2019to 28 Feb 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Global Deterioration Scale (GDS) 2 or 3
Who cannot join
- Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
- Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- History of viral hepatitis or cancer
- Uncontrolled hypertension
- History of serious cardiac disease such as angina or myocardial infarction
- History of gastrectomy
- History of medication for psychiatric disease
- Administration of oriental medicine including herbs within the past 4 weeks
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, 50612
About this study
Official title: Effect of Skate Skin Extract on Cognitive Function in Adults With Subjective Memory Impairment
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks.
Read the detailed description
Previous animal studies have indicated that Skate Skin extract may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;
- Conditions
- Subjective Memory Impairment
- Being tested
- Skate group, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skate groupDietary supplement
This group takes 500 mg/day Skate Skin extract for 12 weeks
Placebo groupDietary supplement
This group takes 500 mg/day Placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Skate group | Experimental | This group takes Skate Skin extract for 12 weeks Receives: Dietary Supplement: Skate group |
| Placebo group | Placebo comparator | This group takes Placebo for 12 weeks Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination total score
Change in Mini-Mental State Examination total score during 3 months
Measured: Change from Baseline Mini-Mental State Examination total score at 3 months
Secondary outcomes (3)
Korean instrumental activity of daily living total score
Change in Korean instrumental activity of daily living total score during 3 months
Measured: Change from Baseline Korean instrumental activity of daily living total score at 3 months
Computerized NeuroCognitive Function test total score
Change in Computerized NeuroCognitive Function test total score during 3 months
Measured: Change from Baseline Computerized NeuroCognitive Function test total score at 3 months
brain derived neurotrophic factor
Change in brain derived neurotrophic factor level during 3 months
Measured: Change from Baseline brain derived neurotrophic factor level at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Feb 2019
- Primary completion14 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Memory 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849391
- Sponsor's protocol ID
- 02-2018-034
- Status last verified
- Mar 2020
- First submitted
- 19 Feb 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skate Skin Extract on Cognitive Function in Adults With Subjective Memory Impairment
- ClinicalTrials.gov ID
- NCT03849391
- Acronym / sponsor ID
- 02-2018-034
- Conditions
- Subjective Memory Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- 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.
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks.
Detailed description
Previous animal studies have indicated that Skate Skin extract may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skate group | Experimental | Dietary Supplement: Skate groupThis group takes Skate Skin extract for 12 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThis group takes Placebo for 12 weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Global Deterioration Scale (GDS) 2 or 3
Key exclusion criteria (8 listed)
- Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL)
- Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
- History of viral hepatitis or cancer
- Uncontrolled hypertension
- History of serious cardiac disease such as angina or myocardial infarction
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 |
|---|---|---|
| Skate groupThis group takes 500 mg/day Skate Skin extract for 12 weeks | Dietary supplement | Skate group |
| Placebo groupThis group takes 500 mg/day Placebo for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
Mini-Mental State Examination total score
Time frame: Change from Baseline Mini-Mental State Examination total score at 3 months
Change in Mini-Mental State Examination total score during 3 months
3 secondary outcomes
Korean instrumental activity of daily living total score
Time frame: Change from Baseline Korean instrumental activity of daily living total score at 3 months
Computerized NeuroCognitive Function test total score
Time frame: Change from Baseline Computerized NeuroCognitive Function test total score at 3 months
brain derived neurotrophic factor
Time frame: Change from Baseline brain derived neurotrophic factor level at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Subjective Memory Impairment
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
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Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI)
Recruiting
Autophagy-Enhancers to Reduce Sleep Disturbances
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A Feasiblity Study of Green Activity Program for People Living With Memory Challenges
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Healthy Aging as Black Adults, In It Together: a Comparative Effectiveness Study of Chronic Pain and Cognitive Decline
Chronic Pain, Physical Activity
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.
Sang Yeoup Lee, MD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skate group in people with Subjective Memory Impairment, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 1 inclusion and 8 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 4 Mar 2020. 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 South Korea. 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.
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?
Mini-Mental State Examination total score (time frame: Change from Baseline Mini-Mental State Examination total score at 3 months). 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 2020.