Rifaximin SSD in Dementia Trial

NCT06718686 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 1817324
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Using a new formulation of rifaximin, a non-absorbable antibiotic, to test if it can affect microbes in the gut of patients with dementia favorably.

Conditions

Dementia Alzheimer Type; Dementia Associated With Cerebrovascular Disease

Keywords

dementia; rifaximin; gut-brain; Alzheimer's; vascular dementia

Outcome Measures

Primary Outcomes (2)

• Change in stool and serum short-chain fatty acid levels

  Change in SCFA in stool and serum in rifaximin SSD phase vs placebo phase

  10 weeks

• Change in bile acids in stool and serum

  Change in bile acids in stool and serum in rifaximin SSD phase vs placebo phase

  10 weeks

Secondary Outcomes (14)

• Systemic inflammatory change

  10 weeks

• Stool microbiome composition

  10 weeks

• Change in dementia biomarkers

  10 weeks

• MMSE

  10 weeks

• Cognitive testing using Psychometric Hepatic Encephalopathy Score

  10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will be given placebo and actual drug sequentially with the order hidden

Drug: Placebo

Rifaximin SSD 40mg IR BID

EXPERIMENTAL

Patients will be given placebo and actual drug sequentially with the order hidden

Drug: Rifaximin SSD 40 mg IR tablet

Interventions

Rifaximin SSD 40 mg IR tablet DRUG

Drug therapy vs placebo

Rifaximin SSD 40mg IR BID

Placebo DRUG

Placebo drug

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Probable Alzheimer's Disease (AD) or Vascular Dementia (VaD) mild or moderate based on Clinical Dementia Rating Scale.
• Males and Females Age ≥ 65 years
• Community living with availability of caregiver to accompany participant to study visits and to participate in the study.
• Able to consent or legal guardian who can consent (with participant assent).
• Legally authorized representative (LAR) and caregiver for the study is the same individual.
• Fluency (both participant and caregiver) in written and spoken English to participate in study visits.

You may not qualify if:

• Dementia not due to AD or VaD
• Clinically significant agitation or aggression (requiring treatment with antipsychotic medication)
• Delusions and/or hallucinations
• Severe psychopathology including major depression
• Unstable, severe, or poorly controlled medical conditions evident from physical examination or clinical history
• Visual and/or hearing disorder that prevents completion of neuropsychologic evaluations.
• Diarrhea
• Hypersensitivity to rifaximin, components of rifaximin,
• and any rifamycin antimicrobial agent
• Antibiotic use in the prior 6 months
• Taking medications that interact with Rifaximin. P-glycoprotein (P-gp) inhibitor treatment is permitted as long as the use of P-gp inhibitors is discussed with the investigator.
• History of alcohol and/or drug abuse
• Participation in another investigational drug trial in the last 30 days

Sponsors & Collaborators

• Jasmohan Bajaj: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Richmond VA Medical Center

Richmond, Virginia, 23249, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Dementia, Vascular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jasmohan Bajaj

  Richmond VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasmohan S Bajaj, MD

CONTACT

804-675-5802; jasmohan.bajaj@vcuhealth.org

Haley Obolewicz, RN

CONTACT

804-675-5705; haley.obolewicz@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 30, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)