Safety Clinical Trial - Curcumin & Retinal Study

Status Recruiting

Clinical Trial Summary

To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance/composition of gut microbiota.

Clinical Trial Description

Alzheimer's disease (AD) leads to progressive cognitive decline. Increased amyloid beta (Aβ) burden and Aβ deposits have been shown in the AD retina. Aβ accumulation inside retinal pericytes in AD and pericyte degeneration in the retina mirror prominent features of brain AD pathology. Curcumin, a derivative of turmeric, has a high affinity for amyloid beta. Thus, curcumin would bind to amyloid beta plaques and emit a strong fluorescent signal, suggesting it can be a powerful diagnostic tool for AD. Emerging evidence has shown the connection between the brain and GI tract (gut microbiome), and its potential implications for both metabolic and neurologic diseases including AD. This pilot study is to test how two weeks of curcumin supplementation would cross the blood brain barrier and attach to amyloid beta proteins and to explore the resulting abundance/composition of gut microbiota. The investigators plan to recruit subjects through direct person-to-person solicitation in the Ophthalmology clinics, health fairs, community events, flyers, non-solicited email system, campus announcements, Clinical Research Institute Volunteer Database website, local radio, newspapers, senior newsletters, and TV scripts. The Clinical Research Institute Volunteer database will also be queried and potential subjects contacted as requested in their form. The investigators plan to enroll approximately 100-150 patients to obtain 30-40 qualified subjects at the start of the study. After screening, qualified participants will be randomly assigned to a low curcumin group or high curcumin group. Thus, this pilot study would focus on characterizing the distribution, manifestation, and prevalence of curcumin-loaded retinal Aβ deposits in study subjects with existing Aβ plaque (primary outcome). In addition, this study will assess safety, bioavailability, and fecal microbiome composition (secondary outcome). All outcomes will be assessed at baseline and after 2 weeks of intervention. Data will be analyzed statistically. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05774704
Study type	Interventional
Source	Texas Tech University Health Sciences Center
Contact	Chwan-Li (Leslie) Shen, PhD
Phone	8067432815
Email	leslie.shen@ttuhsc.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	August 21, 2023
Completion date	March 31, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Curcumin and Retinal Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms