NCT05060848

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Apr 2021May 2027

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

5.1 years

First QC Date

September 20, 2021

Last Update Submit

March 7, 2023

Conditions

Keywords

biomarkervascular diseasesex differencesrace differences

Outcome Measures

Primary Outcomes (3)

  • Cognitive Outcomes

    ADAS Cog score

    Prospective, single measurement

  • Imaging Outcomes

    MRI based brain volume measures, FLAIR lesion volume

    Prospective, single measurement

  • Blood Outcomes

    Plasma Hydrogen sulfide including metabolites: free, acid labile, bound and total sulfides.

    Prospective, single measurement

Secondary Outcomes (1)

  • Demographic Data

    Prospective, single measurement

Other Outcomes (1)

  • Comorbidity Data (covariates)

    Prospective, single measurement

Study Arms (2)

ADRD

Participants in the ADRD group will have a score of greater than or equal to 17 on the ADAS-cog, a paper and pencil test of cognitive function including memory. Subgroups based on sex and race categories will also be examined.

Control

Participants in the control group will have a score of less than 17 on the ADAS-cog, a paper and pencil test of cognitive function including memory

Eligibility Criteria

Age55 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 50 people with a study based diagnosis of AD (ADAS-cog score ≥17) and 50 controls will be enrolled in the study.

You may qualify if:

  • All participants must be aged \>55 years with English as the 1⁰ 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Health Shreveport Center for Brain Health

Shreveport, Louisiana, 71103, United States

Location

Related 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 Dement. 2021 Aug;17(8):1391-1402. doi: 10.1002/alz.12305. Epub 2021 Mar 12.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Alzheimer DiseaseDementiaVascular Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dept. of Neurology

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 29, 2021

Study Start

April 1, 2021

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations