Subjective Cognitive Decline (SCD)
Conditions
Keywords
Subjective Cognitive Decline, Mild cognitive impairment, probiotics, dietary supplement
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTLacticaseibacillus paracasei
one capsule daily for 12 weeks
Sponsors
Bened Biomedical Co., Ltd.
Chi-Chang Huang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological measures Changes in CANTAB® in 40 subjects after probiotic intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Chinese version of Stroop color words test(SCWT) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | The Stroop Color Words test (SCWT) was used to evaluate the dominant inhibition in executive function |
| Changes in Geriatric Depression Scale in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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. |
| Changes in Anxiety Disorder Assessment (GAD-7) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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 |
| Changes in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16 (QLESQ-16) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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. |
| Changes in Patient Global Impression scales of Improvement rated by patient （PGI-C) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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. |
| Changes in Chinese version of Trail Making Test (TMT) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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 |
| Changes in Plasma Aβ40 and Aβ42 in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | Plasma Aβ42/Aβ40 is sensitive to early cerebral amyloid accumulation and predicts risk of cognitive decline across the Alzheimer's disease spectrum |
| Changes in Brain-derived neurotrophic factor (BDNF) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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. |
| Changes in Glial Fibrillary Acidic Protein (GFAP) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | Glial fibrillary acidic protein (GFAP), an astrocytic cytoskeletal protein, can be measured in blood samples, and has been associated with Alzheimer's disease (AD). |
| Changes in Neurofilament Light (NfL) in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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. |
| Changes in Mandarin Subjective Cognitive Decline Scale (SCDS) in 40 subjects after probiotic intervention | screening, baseline to 12 weeks assessed | 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. |
| Changes in pTau-217 in 40 subjects after probiotic intervention | baseline to 12 weeks assessed | 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. |
Countries
Taiwan
Outcome results
None listed