SCV09 synbiotic for improving behavioral symptoms in Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot, single-arm study administering the synbiotic formula SCV09 to patients with Alzheimer's disease who meet preset cognitive and behavioral thresholds. Eligible participants aged 60–85 with HK-MoCA ≤20 and NPI-12 ≥10 and a stable Alzheimer's medication history will receive SCV09 while being monitored for safety and changes in behavior. Clinical visits and stool sample collection will be used to track behavioral outcomes and explore gut microbiota changes associated with treatment. Findings are intended to estimate efficacy and safety and to inform the design of a future larger randomized controlled trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals aged between 60-85 with a clinical diagnosis of Alzheimer's disease
* Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score of ≤20
* Neuropsychiatric Inventory-Questionnaire (NPI-12) ≥10
* Stable medication history for Alzheimer's disease within the past 4 weeks
* Have been taken care by a responsible caregiver who could assist the patient in taking the study products, collecting stool samples and attending the clinical follow-up •-Able to provide informed consent

Exclusion Criteria:

* Concomitant Parkinson's disease and other neurodegenerative conditions affecting activities of daily living
* History of stroke
* History of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection
* Confirmed active malignancy
* Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months
* Use of anti-psychotics, antidepressants or sedatives, unless on a stable dose in the last 3 months
* Inability to receive oral fluids
* Use of antibiotics, probiotics or prebiotics in the last 2 weeks
* Intolerance to probiotics or lactose

Where it's running

• The Chinse University of Hong Kong
  Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Professor Timothy Kwok — Chinese University of Hong Kong
• Study coordinator: Professor Timothy Kwok
• Email: tkwok@cuhk.edu.hk
• Phone: +852 35053145

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blood biomarker cohort for memory disorders in older adults

  This observational cohort will collect blood samples and brain imaging data from adults 50+ with memory disorders and a small group of healthy young adults to help find biomarkers.

  Recruiting Yonsei University · Seoul, Seodamun-gu · NCT07880275

• Tau changes after hip or knee replacement surgery

  Researchers will see if brain tau changes after hip or knee surgery and whether these changes relate to inflammation and thinking abilities.

  Recruiting Uppsala University Hospital · Uppsala · NCT07871487

• Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Mild Alzheimer's Dementia

  This study will test whether a low-dose brain radiation treatment using HeLaXON helps people with mild Alzheimer's dementia improve or stabilize thinking and daily function.

  Recruiting ReadyCure Inc. · Cheonan, Chungcheongnam-do · NCT07863011

• Cervical lymphatic surgery to see if it helps people with mild Alzheimer’s

  We’re testing a surgical approach in people with mild Alzheimer’s to see if creating alternative neck lymph drainage routes can affect brain biomarkers and daily function.

  Recruiting at 2 sites Maliszewski Daniel · Gdansk and 1 other locations · NCT07857759

• Transcranial random noise stimulation for behavioral and psychological symptoms in Alzheimer's disease

  This trial tests whether high-frequency transcranial random noise stimulation can help people with early Alzheimer's disease who have BPSD, compared to a sham treatment.

  Recruiting Anhui Medical University · Hefei, Anhui · NCT07827196

• Testing LY4405094 in healthy people and people with Alzheimer’s disease

  This study tests LY4405094 to see if it is safe and how it behaves in the body, including how it reaches the brain fluid in healthy participants and how it affects a brain protein in people with Alzheimer's disease.

  Recruiting Phase 1 Eli Lilly and Company · Anaheim, California and 17 other locations · NCT07787182

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.