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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05774704
Other study ID # Curcumin-Retinal Pilot Study
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 21, 2023
Est. completion date March 31, 2025

Study information

Verified date August 2023
Source Texas Tech University Health Sciences Center
Contact Chwan-Li (Leslie) Shen, PhD
Phone 8067432815
Email leslie.shen@ttuhsc.edu
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 89 Years
Eligibility Inclusion: - Both male and female, age 40 - 89 years. - Diagnosed with Aß deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aß deposits in retina within 6 months before the consent session, we will use this diagnosis/documentation for eligibility criteria. Otherwise, the ophthalmic exam will be repeated after consent is obtained for the study. - No pre-existing liver or kidney diseases by self-report. Exclusion: - Patients with ocular diseases (macular degeneration, severe diabetes retinopathy) - Had used systemic antibiotics within 1 month prior to the start of the study intervention - Had taken any turmeric or curcumin products within 2 weeks prior to the start of the study intervention - Had a known allergy to black pepper - Women that are pregnant or breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Low curcumin group
One curcumin capsule (250 mg curcumin) after each meal, 3 times a day for 2 weeks.
High curcumin group
One curcumin capsule (500 mg curcumin) after each meal, 3 times a day for 2 weeks.

Locations

Country Name City State
United States Texas Tech University Health Sciences Center Lubbock Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal imaging- amyloid fluorescent intensity To access amyloid fluorescent intensity Baseline
Primary Retinal imaging-amyloid fluorescent deposit number To access amyloid fluorescent deposit number Baseline
Primary Retinal imaging-amyloid fluorescent location To access amyloid fluorescent location Baseline
Primary Retinal imaging-amyloid fluorescent intensity To access amyloid fluorescent intensity After 2 weeks
Primary Retinal imaging-amyloid fluorescent deposit number To access amyloid fluorescent deposit number After 2 weeks
Primary Retinal imaging-amyloid fluorescent location To access amyloid fluorescent location After 2 weeks
Secondary Bioavailability- curcumin concentrations in plasma To measure curcumin concentrations in plasma Baseline
Secondary Bioavailability-curcumin concentrations in red blood cells To measure curcumin concentrations in red blood cells Baseline
Secondary Bioavailability-curcumin concentrations in plasma To measure curcumin concentrations in plasma After 2 weeks
Secondary Bioavailability-curcumin concentrations in red blood cells To measure curcumin concentrations in red blood cells After 2 weeks
Secondary Liver function-serum AST To assess serum AST Baseline
Secondary Liver function-serum ALT To assess serum ALT Baseline
Secondary Kidney function-serum BUN To assess serum BUN Baseline
Secondary Liver function-serum ALT To assess serum ALT After 2 weeks
Secondary Kidney function-serum BUN To assess serum BUN After 2 weeks
Secondary Gut microbiome-abundance To measure the abundance of intestinal bacterial in feces Baseline
Secondary Gut microbiome-composition To measure the composition of intestinal bacterial in feces Baseline
Secondary Gut microbiome-abundance To measure the abundance of intestinal bacterial in feces After 2 weeks
Secondary Gut microbiome-composition To measure the composition of intestinal bacterial in feces After 2 weeks
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