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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05060848
Other study ID # 00000059
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date May 2027

Study information

Verified date March 2023
Source Louisiana State University Health Sciences Center Shreveport
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hydrogen sulfide is a signaling molecule that is important for vascular health. Because vascular factors such as hypertension and high cholesterol are risk factors for Alzheimer's disease and related dementias, we hypothesize that hydrogen sulfide plays an important role in brain health as well. We will compare blood levels of hydrogen sulfide across groups of people with and without dementia. We will also look at the relationship between hydrogen sulfide, cognitive dysfunction and measures of brain microvascular disease examine the contribution of hydrogen sulfide to cognitive decline. Our goal is to identify a biomarker of vascular dysfunction in dementia.


Description:

We have described hydrogen sulfide (H2S), a signaling molecule important in vascular homeostasis, as a biomarker of cardiovascular disease. There is accumulating evidence that vascular factors such as hypertension, hypercholesterolemia, and type 2 diabetes are associated with increased risk of Alzheimer's disease and related dementias (ADRD). Furthermore, in the brain, H2S acts as a neurotransmitter/second messenger produced following nerve excitation. It also modulates N-methyl-D-aspartate (NMDA) receptors during long term potentiation for memory consolidation. Three biochemical forms of reactive sulfur pools exist: free H2S, acid-labile (e.g. iron-sulfur clusters) and bound sulfide (e.g. persulfides, polysulfides). We hypothesize that H2S becomes dysregulated in ADRD, where vascular and cognitive functions are linked. We will use analytical biochemical methods to measure plasma H2S and its metabolites, and 3T MRI to evaluate indicators of microvascular disease in ADRD. We will compare H2S levels in people with and without cognitive dysfunction consistent with ADRD, and determine the specificity and sensitivity of H2S indistinguishing people with and without cognitive dysfunction. In addition, because previous studies report differences in the incidence and prevalence of ADRD by race and sex, we will compare outcomes across these groups as well. Finally, we will examine the potentially mediating role of H2S in the relationship between cognitive function and microvascular disease.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date May 2027
Est. primary completion date May 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 100 Years
Eligibility Inclusion Criteria: - All participants must be aged >55 years with English as the 1° language, with stable permitted medications for <4 weeks, geriatric depression scale score <6, visual and auditory acuity adequate to perform tests, and history of education excluding developmental cognitive abnormalities. Exclusion Criteria: - Exclusion criteria are history of significant neurologic disease or mental illness, unstable medical conditions that could interfere with completion of study, substance abuse within 2 years, contraindications to MRI, abnormal findings on MRI, history of chronic kidney disease, and investigational agents within 1 month of participation.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States LSU Health Shreveport Center for Brain Health Shreveport Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Louisiana State University Health Sciences Center Shreveport

Country where clinical trial is conducted

United States, 

References & Publications (1)

Disbrow E, Stokes KY, Ledbetter C, Patterson J, Kelley R, Pardue S, Reekes T, Larmeu L, Batra V, Yuan S, Cvek U, Trutschl M, Kilgore P, Alexander JS, Kevil CG. Plasma hydrogen sulfide: A biomarker of Alzheimer's disease and related dementias. Alzheimers D — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Comorbidity Data (covariates) BP, weight, Hx of smoking, diabetes, hypertension, elevated cholesterol Prospective, single measurement
Primary Cognitive Outcomes ADAS Cog score Prospective, single measurement
Primary Imaging Outcomes MRI based brain volume measures, FLAIR lesion volume Prospective, single measurement
Primary Blood Outcomes Plasma Hydrogen sulfide including metabolites: free, acid labile, bound and total sulfides. Prospective, single measurement
Secondary Demographic Data Age, Race, Sex, Socioeconomic status Prospective, single measurement
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