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NCT06948929 | NOT YET RECRUITING | Alzheimer Disease

Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Sponsor:

Chinese University of Hong Kong

Information provided by (Responsible Party):

Timothy Kwok

Brief Summary:

In recent years, emerging studies have revealed the role of gut microbiota in human health and diseases, including AD and other neurodegenerative conditions5. Although the underlying mechanism is still largely unknown, successful therapies targeting the gut-brain axis may serve as indirect evidence of the possible linkage. This pilot, single-arm study aims to estimate the efficacy and assess the safety profile of the use of a new synbiotic formula (SCV09) in improving dementia-related behaviour in Alzheimer's disease patients, paving the way for a large-scale randomised controlled trial in the future.

Condition or disease

Alzheimer Disease

Intervention/treatment

a synbiotic formula (SCV09)

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Pilot, Single-arm Study on the Efficacy and Safety of the Use of a Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Actual Study Start Date : 2025-05-15
Estimated Primary Completion Date : 2026-05-15
Estimated Study Completion Date : 2026-12-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Synbiotic Formula (SCV09) in Alzheimer's Disease Patients

Location Details

NCT06948929

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Hong Kong,

The Chinese University of Hong Kong

Shin, Hong Kong,