Subjective Cognitive Decline (SCD)NCT07168824
An Open Label Trial Evaluating the Efficacy of Lacticaseibacillus Paracasei PS23 on Cognition
A study testing Lacticaseibacillus paracasei in people with Subjective Cognitive Decline (SCD), run by Chi-Chang Huang at 1 site in Taiwan.
Trial summary
This open label study aims to evaluate whether the consumption of probiotics can improve symptoms and overall quality of life in individuals experiencing cognitive decline symptoms, as well as to evaluate the effects of probiotics on blood-related biomarkers. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline (SCD)
- What is being tested?
- Lacticaseibacillus paracasei
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Oct 2025to 2 Apr 2026
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 50 to 85 years who self-report experiencing signs of cognitive decline.
- No prior diagnosis of dementia or Alzheimer's disease (AD).
- Willing and able to comply with study assessments and requirements, and provide written informed consent.
Who cannot join
- Use of antibiotics or probiotic powder, capsules, or tablets within the past month.
- Currently undergoing antibiotic treatment.
- Known allergy to dairy products.
- Presence of immunodeficiency or impaired immune function.
- Diagnosis of small intestinal bacterial overgrowth (SIBO).
- Determined unsuitable by the investigator, for example, initiation of any new medication or therapy during the study period, particularly those related to memory impairment or cognitive decline.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Graduate Institute of Sports Science, National Taiwan Sport University
Taoyuan, 33301
About this study
This open label study aims to evaluate whether the consumption of probiotics can improve symptoms and overall quality of life in individuals experiencing cognitive decline symptoms, as well as to evaluate the effects of probiotics on blood-related biomarkers.
Read the detailed description
Lacticaseibacillus paracasei PS23 (PS23) is a specific strain of probiotic bacteria known for its potential health benefits, particularly in the context of aging and muscle health. Research suggests that it may improve cognitive function, reduce age-related muscle loss, and modulate the gut microbiota. Probiotic supplements like PS23 are being explored as potential therapeutic agents for age-related cognitive deficits. A prior study showed that PS23 supplementation delayed age-related cognitive decline in mice. Additionally, PS23 has shown antidepressant-like effects and has been found to enhance physical performance and promote muscle recovery following injury.
- Conditions
- Subjective Cognitive Decline (SCD)
- Being tested
- Lacticaseibacillus paracasei
- Keywords
- Subjective Cognitive Decline, Mild cognitive impairment, probiotics, dietary supplement
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus paracaseiDietary supplement
Also called PS23
one capsule daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Lacticaseibacillus paracasei PS23 one capsule daily for 12 weeks Receives: Dietary Supplement: Lacticaseibacillus paracasei |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention
Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests that are correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance.
Measured: baseline to 12 weeks assessed
Secondary outcomes (12)
Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention
The Trail Making Task (TMT) is a neuropsychological test consisting of two parts that assesses executive function, visual attention, speed of processing, and cognitive flexibility. In Part A, the participant connects 25 numbered circles in sequential numerical order (1 to 25) as quickly and accurately as possible. TMT-B with sequential numbers in the Chinese characters substituting for the English alphabetical sequence, replaced numbers and letters of the TMT-B by circles and squares with numbers, modified the TMT-B with the Chinese zodiacs substituting for the English alphabet
Measured: baseline to 12 weeks assessed
Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention
The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function
Measured: baseline to 12 weeks assessed
Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention
The Geriatric Depression Scale (GDS) is a screening tool for depression in older adults (55+), consisting of a short, yes/no questionnaire about feelings over the past week. Scores range between 0 and 30 points. Higher scores indicate more severe depressive symptoms.
Measured: baseline to 12 weeks assessed
Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention
The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day"
Measured: baseline to 12 weeks assessed
Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention
The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 is a valid, reliable self-report instrument for assessing quality of life. The minimum raw score on the Q-LES-Q-16 is 14, and the maximum score is 70, higher scores mean a better outcome.
Measured: baseline to 12 weeks assessed
Changes in Patient Global Impression scales of Improvement rated by patient (PGI-C) in 40 subjects after probiotic intervention
The PGIC consists of one item taken from the clinical global impression and adapted to the patient. The minimum total score possible is 1 and the maximum total score possible is 7. Higher values represent a worse outcome.
Measured: baseline to 12 weeks assessed
Changes in pTau-217 in 40 subjects after probiotic intervention
Recent, research studies have shown that plasma levels of p-Tau 217 are elevated in AD patients1,2. Additionally, it has been demonstrated that plasma p-Tau 217 levels are increased in the early stages of the AD continuum and are correlated with amyloid-PET positivity.
Measured: baseline to 12 weeks assessed
Changes in Plasma Aβ40 and Aβ42 in 40 subjects after probiotic intervention
Plasma Aβ42/Aβ40 is sensitive to early cerebral amyloid accumulation and predicts risk of cognitive decline across the Alzheimer's disease spectrum
Measured: baseline to 12 weeks assessed
Changes in Brain-derived neurotrophic factor (BDNF) in 40 subjects after probiotic intervention
Brain-derived neurotrophic factor (BDNF) plays an important role in neuronal survival and growth, serves as a neurotransmitter modulator, and participates in neuronal plasticity, which is essential for learning and memory.
Measured: baseline to 12 weeks assessed
Changes in Glial Fibrillary Acidic Protein (GFAP) in 40 subjects after probiotic intervention
Glial fibrillary acidic protein (GFAP), an astrocytic cytoskeletal protein, can be measured in blood samples, and has been associated with Alzheimer's disease (AD).
Measured: baseline to 12 weeks assessed
Changes in Neurofilament Light (NfL) in 40 subjects after probiotic intervention
Neurofilament light chain (NfL) is a structural protein that normally helps support the shape and function of brain cells. In Alzheimer's disease (AD), brain cells are damaged, which causes the brain to shrink (atrophy), and symptoms such as declining cognition to occur.
Measured: baseline to 12 weeks assessed
Changes in Mandarin Subjective Cognitive Decline Scale (SCDS) in 40 subjects after probiotic intervention
Self-reported questionnaire consisting of 14 items assessing perceived decline in memory, attention, language, planning, orientation, and other cognitive domains. Responses are typically rated on a Likert scale (e.g., 0 = "Never" to 4 = "Very frequently"), with total scores ranging from 0 to 56-higher scores indicate greater subjective cognitive complaints.
Measured: screening, baseline to 12 weeks assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start17 Oct 2025
- Primary completion31 Jan 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive Decline (SCD)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi-Chang Huang
- Sponsor type
- University, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Responsible party
- Sponsor-investigator, Chi-Chang Huang, National Taiwan Sport University
- Investigators
- Chi-Chang Huang, PhD, Principal investigator, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168824
- Sponsor's protocol ID
- IRB-25-061-A2
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial Evaluating the Efficacy of Lacticaseibacillus Paracasei PS23 on Cognition
- ClinicalTrials.gov ID
- NCT07168824
- Acronym / sponsor ID
- IRB-25-061-A2
- Conditions
- Subjective Cognitive Decline (SCD)
- Keywords
- Subjective Cognitive Decline, Mild cognitive impairment, probiotics, dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chi-Chang HuangUniversity, hospital or other
- Collaborators
- Bened Biomedical Co., Ltd.
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 11 Sep 2025 (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.
This open label study aims to evaluate whether the consumption of probiotics can improve symptoms and overall quality of life in individuals experiencing cognitive decline symptoms, as well as to evaluate the effects of probiotics on blood-related biomarkers.
Detailed description
Lacticaseibacillus paracasei PS23 (PS23) is a specific strain of probiotic bacteria known for its potential health benefits, particularly in the context of aging and muscle health. Research suggests that it may improve cognitive function, reduce age-related muscle loss, and modulate the gut microbiota. Probiotic supplements like PS23 are being explored as potential therapeutic agents for age-related cognitive deficits. A prior study showed that PS23 supplementation delayed age-related cognitive decline in mice. Additionally, PS23 has shown antidepressant-like effects and has been found to enhance physical performance and promote muscle recovery following injury.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Lacticaseibacillus paracaseiLacticaseibacillus paracasei PS23 one capsule daily for 12 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 50 to 85 years who self-report experiencing signs of cognitive decline.
- No prior diagnosis of dementia or Alzheimer's disease (AD).
- Willing and able to comply with study assessments and requirements, and provide written informed consent.
Key exclusion criteria (6 listed)
- Use of antibiotics or probiotic powder, capsules, or tablets within the past month.
- Currently undergoing antibiotic treatment.
- Known allergy to dairy products.
- Presence of immunodeficiency or impaired immune function.
- Diagnosis of small intestinal bacterial overgrowth (SIBO).
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 |
|---|---|---|
| Lacticaseibacillus paracaseiAlso: PS23one capsule daily for 12 weeks | Dietary supplement | Probiotics |
Primary outcome
Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Cambridge Neuropsychological Test Automated Battery (CANTAB®) includes computerized tests that are correlated to neural networks and have demonstrated high sensitivity in detecting changes in neuropsychological performance.
12 secondary outcomes
Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Patient Global Impression scales of Improvement rated by patient (PGI-C) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in pTau-217 in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Plasma Aβ40 and Aβ42 in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Brain-derived neurotrophic factor (BDNF) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Glial Fibrillary Acidic Protein (GFAP) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Neurofilament Light (NfL) in 40 subjects after probiotic intervention
Time frame: baseline to 12 weeks assessed
Changes in Mandarin Subjective Cognitive Decline Scale (SCDS) in 40 subjects after probiotic intervention
Time frame: screening, baseline to 12 weeks assessed
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 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Chi-Chang Huang, PhD principal investigator
National Taiwan Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lacticaseibacillus paracasei in people with Subjective Cognitive Decline (SCD), run by Chi-Chang Huang at 1 site in Taiwan.
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 3 inclusion and 6 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 25 Sep 2026. 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 Taiwan. 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. 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?
Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention (time frame: baseline to 12 weeks assessed). 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 25 Sep 2026.