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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.

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

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

Other trials in Taiwan

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.

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 groups in NCT07168824
Study groupRoleWhat they receive
ProbioticsExperimentalLacticaseibacillus 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted11 Sep 2025
  2. Study start17 Oct 2025
  3. Primary completion31 Jan 2026
  4. Study completion2 Apr 2026

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 N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
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

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.

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