Healthy Japanese SubjectsNCT05962008
Effects of Consumption of Phosphatidylserine on the Cognitive Function
A study testing DHAPS® product and BioPS® product in people with Healthy Japanese Subjects, run by Orthomedico Inc. at 2 sites in Japan.
Trial summary
The main objective of this trial is to verify the effects of consumption of phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese Subjects
- What is being tested?
- DHAPS® product and BioPS® product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 2 sitesJapan
- Study dates
- 20 Jul 2023to 17 Mar 2024
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese
- Male and female
- Subjects aged 35-65
- Healthy subjects
- Subjects who notice a decline in memory
- Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more
- Subjects who met the inclusion criteria 1. ~ 6. and have relatively low standardized score in composite memory measured using Cognitrax at Scr (Selection of those with relatively low standardized scores will be conducted in blocks of "Subjects aged 50 or over" and "Subjects aged under 50")
- Subjects who are judged as eligible to participate in the study by the physician
Who cannot join
- Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
- Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
- Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- Subjects who have dementia
- Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
- Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage, as part of their daily intake
Show all 14Show fewer
- Subjects who take supplements or foods that may improve cognitive functions, such as phosphatidylserine, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and plasmalogen, as part of their daily intake
- Subjects who take blue-backed fish such as sardines, mackerel, and saury for 4 days/week or over
- Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) as part of their daily life
- Subjects regularly taking medications (including herbal medicines) and supplements
- Subjects who are allergic to medications and/or the test food related products
- Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period
- Subjects who have been enrolled in other clinical trials 28 days before the agreement to participate in this trial or those who plan to enroll in another clinical trial during the trial period
- Subjects who are deemed ineligible to participate by the principal investigator
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Nerima Medical Association Minami-machi Clinic
Nerima-ku, Tokyo, 176-0002
Medical Corporation Seishinkai, Takara Clinic
Shinagawa-ku, Tokyo, 141-0022
About this study
Official title: Effects of Consumption of Phosphatidylserine on the Cognitive Function: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
The main objective of this trial is to verify the effects of consumption of phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects.
Read the detailed description
In this study, the investigators will evaluate the cognitive function before and after the intervention. The groups to be compared are omega-3-phosphatidylserine derived from herring roe, phosphatidylserine derived from soybean, and a placebo.
- Conditions
- Healthy Japanese Subjects
- Being tested
- DHAPS® product, BioPS® product, Placebo
- Keywords
- Phosphatidylserine, Cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHAPS® productDietary supplement
Take 4 capsules per day after breakfast with warm water.
BioPS® productDietary supplement
Take 4 capsules per day after breakfast with warm water.
PlaceboDietary supplement
Take 4 capsules per day after breakfast with warm water.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3-phosphatidylserine derived from herring roe | Active comparator | Take 300 mg/day of omega-3-phosphatidylserine derived from herring roe. Receives: Dietary Supplement: DHAPS® product |
| Phosphatidylserine derived from soybean | Active comparator | Take 300 mg/day of phosphatidylserine derived from soybean. Receives: Dietary Supplement: BioPS® product |
| Placebo | Placebo comparator | Take 0 mg/day of phosphatidylserine. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measured value of the standardized score of composite memory at Week 12
Verbal Memory (VBM) test and Visual Memory (VIM) test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
Secondary outcomes (31)
The amount of change of the standardized score of composite memory between Base line and Week 12
VBM test and VIM test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of neurocognition index (NCI) at Week 12
Seven neurocognitive tests {VBM, VIM, Finger Tapping (FTT), Symbol Digit Coding (SDC), Stroop Test (ST), Shifting Attention (SAT), and Continuous Performance (CPT)} are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of NCI is calculated from results of these seven tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of NCI between Base line and Week 12
Seven neurocognitive tests {VBM, VIM, FTT, SDC, ST, SAT, and CPT} are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of NCI is calculated from results of these seven tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of verbal memory at Week 12
VBM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of verbal memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of verbal memory between Base line and Week 12
VBM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of verbal memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of visual memory at Week 12
VIM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of visual memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of visual memory between Base line and Week 12
VIM test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of visual memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of psychomotor speed at Week 12
FTT test and SDC test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of psychomotor speed is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of psychomotor speed between Base line and Week 12
FTT test and SDC test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of psychomotor speed is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of reaction time at Week 12
ST test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reaction time is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of reaction time between Base line and Week 12
ST test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reaction time is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of complex attention at Week 12
ST test, SAT test, and CPT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of complex attention is calculated from results of these three tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of complex attention between Base line and Week 12
ST test, SAT test, and CPT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of complex attention is calculated from results of these three tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of cognitive flexibility at Week 12
ST test and SAT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of cognitive flexibility is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of cognitive flexibility between Base line and Week 12
ST test and SAT test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of cognitive flexibility is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of processing speed at Week 12
SDC test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of processing speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of processing speed between Base line and Week 12
SDC test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of processing speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of executive function at Week 12
SAT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of executive function is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of executive function between Base line and Week 12
SAT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of executive function is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of social acuity at Week 12
Perception of Emotions (POET) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of social acuity is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of social acuity between Base line and Week 12
POET test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of social acuity is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of reasoning at Week 12
Non-Verbal Reasoning (NVRT) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reasoning is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of reasoning between Base line and Week 12
NVRT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of reasoning is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of working memory at Week 12
4-Part Continuous Performance (FPCPT) test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of working memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of working memory between Base line and Week 12
FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of working memory is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of sustained attention at Week 12
FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of sustained attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of sustained attention between Base line and Week 12
FPCPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of sustained attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of simple attention at Week 12
CPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of simple attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of simple attention between Base line and Week 12
CPT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of simple attention is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
The measured value of the standardized score of motor speed at Week 12
FTT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of motor speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Week 12
The amount of change of the standardized score of motor speed between Base line and Week 12
FTT test is measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of motor speed is calculated from the result of this test. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
Measured: Base line and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start20 Jul 2023
- Primary completion17 Mar 2024
- Study completion17 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese SubjectsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthomedico Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- ECA Healthcare Inc.
- Responsible party
- Sponsor
- Investigators
- Tsuyoshi Takara, MD, Principal investigator, Medical Corporation Seishinkai, Takara Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962008
- Sponsor's protocol ID
- 06788-0019-10
- Status last verified
- Aug 2024
- First submitted
- 4 Jul 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be discussed among the research affiliates after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Consumption of Phosphatidylserine on the Cognitive Function: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
- ClinicalTrials.gov ID
- NCT05962008
- Acronym / sponsor ID
- 06788-0019-10
- Conditions
- Healthy Japanese Subjects
- Keywords
- Phosphatidylserine, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Orthomedico Inc.University, hospital or other
- Collaborators
- ECA Healthcare Inc.
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 17 Mar 2024 (actual)
- Study completion
- 17 Mar 2024 (actual)
- First posted
- 27 Jul 2023 (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 main objective of this trial is to verify the effects of consumption of phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects.
Detailed description
In this study, the investigators will evaluate the cognitive function before and after the intervention. The groups to be compared are omega-3-phosphatidylserine derived from herring roe, phosphatidylserine derived from soybean, and a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omega-3-phosphatidylserine derived from herring roe | Active comparator | Dietary Supplement: DHAPS® productTake 300 mg/day of omega-3-phosphatidylserine derived from herring roe. |
| Phosphatidylserine derived from soybean | Active comparator | Dietary Supplement: BioPS® productTake 300 mg/day of phosphatidylserine derived from soybean. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake 0 mg/day of phosphatidylserine. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Japanese
- Male and female
- Subjects aged 35-65
- Healthy subjects
- Subjects who notice a decline in memory
Key exclusion criteria (14 listed)
- Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
- Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
- Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- Subjects who have dementia
- Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
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 |
|---|---|---|
| DHAPS® productTake 4 capsules per day after breakfast with warm water. | Dietary supplement | Omega-3-phosphatidylserine derived from herring roe |
| BioPS® productTake 4 capsules per day after breakfast with warm water. | Dietary supplement | Phosphatidylserine derived from soybean |
| PlaceboTake 4 capsules per day after breakfast with warm water. | Dietary supplement | Placebo |
Primary outcome
The measured value of the standardized score of composite memory at Week 12
Time frame: Week 12
Verbal Memory (VBM) test and Visual Memory (VIM) test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
31 secondary outcomes
The amount of change of the standardized score of composite memory between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of neurocognition index (NCI) at Week 12
Time frame: Week 12
The amount of change of the standardized score of NCI between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of verbal memory at Week 12
Time frame: Week 12
The amount of change of the standardized score of verbal memory between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of visual memory at Week 12
Time frame: Week 12
The amount of change of the standardized score of visual memory between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of psychomotor speed at Week 12
Time frame: Week 12
The amount of change of the standardized score of psychomotor speed between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of reaction time at Week 12
Time frame: Week 12
The amount of change of the standardized score of reaction time between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of complex attention at Week 12
Time frame: Week 12
The amount of change of the standardized score of complex attention between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of cognitive flexibility at Week 12
Time frame: Week 12
The amount of change of the standardized score of cognitive flexibility between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of processing speed at Week 12
Time frame: Week 12
The amount of change of the standardized score of processing speed between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of executive function at Week 12
Time frame: Week 12
The amount of change of the standardized score of executive function between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of social acuity at Week 12
Time frame: Week 12
The amount of change of the standardized score of social acuity between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of reasoning at Week 12
Time frame: Week 12
The amount of change of the standardized score of reasoning between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of working memory at Week 12
Time frame: Week 12
The amount of change of the standardized score of working memory between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of sustained attention at Week 12
Time frame: Week 12
The amount of change of the standardized score of sustained attention between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of simple attention at Week 12
Time frame: Week 12
The amount of change of the standardized score of simple attention between Base line and Week 12
Time frame: Base line and Week 12
The measured value of the standardized score of motor speed at Week 12
Time frame: Week 12
The amount of change of the standardized score of motor speed between Base line and Week 12
Time frame: Base line and Week 12
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 2 Aug 2024.
- Individual participant dataSharing planned: No. Data sharing will be discussed among the research affiliates after the study is completed.
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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.
Tsuyoshi Takara, MD principal investigator
Medical Corporation Seishinkai, Takara Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHAPS® product and BioPS® product in people with Healthy Japanese Subjects, run by Orthomedico Inc. at 2 sites in Japan.
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 14 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 2 Aug 2024. 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 Japan. 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?
The measured value of the standardized score of composite memory at Week 12 (time frame: Week 12). 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 2 Aug 2024.