TA-65 and Aging Associated Microvascular Dysfunction | NCT05598359

Studies
TA-65 and Aging Associated Microvascular Dysfunction

NCT05598359

Sponsor

Medical College of Wisconsin

Status

Not yet recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Telomere Shortening
Aging
Vascular Diseases

Interventions

TA-65
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2027Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Oct 18, 2022

First Submission Date that Met QC Criteria

Oct 24, 2022

First Posted Date

Oct 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

May 1, 2026Actual

Name	Class
University of Louisville	OTHER
Penn State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to test whether activation of telomerase with a dietary supplement (TA-65) improves microvascular function.

Detailed Description

The purpose of this clinical trial is to examine whether activation of autophagy with TA-65 which activates telomerase, improves microvascular function and blood pressure in an older population

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TA-65	Experimental	TA-65 (250 U) taken once per day	Dietary Supplement: TA-65
Placebo	Placebo Comparator	Placebo taken once per day	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TA-65	Dietary Supplement	TA-65 is a purified small molecule extracted from Astragalus root	TA-65

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis	Cutaneous microvascular function measured via laser Doppler flowmetry coupled with intradermal microdialysis of non-specific nitric oxide synthase inhibitor, L-NAME	28 days

Secondary Outcomes

Measure	Description	Time Frame
Systemic Blood Pressure	Brachial systolic, and diastolic blood pressure will be measured via standard brachial blood pressure cuff	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Adults 18 - 35 and 65+ years of age
Subjects with clinical diagnosis of CAD

Exclusion criteria will include:

36-64 years of age without clinical diagnosis of CAD
Self-reported habitual vigorous exercise (>20 min, 3 times per week, 1 yr)
Major Adverse Cardiovascular Event (MACE) in the last year (heart attack, stroke)
Heart Failure
Renal Impairment
>3 Pre-existing Cardiovascular Risk Factors (healthy groups only)
Type 1 or type 2 diabetes
Uncontrolled hypertension
Current tobacco use or within last 6 months
BMI > 35
Hyperlipidemia
Hypercholesterolemia
Use of anti-coagulant drugs
Use of anti-platelet drugs
Erectile dysfunction medication in the past 6 months
Use of topical/non-topical steroids in last 6 months
Hormone replacement therapy (Post-Menopause or Gender Reassignment)
History of retinopathy
Documented neuromuscular disorders
Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)
Pregnancy (young female subjects)
Allergy to lidocaine
Current diagnosis of cancer with or without active anti-cancer treatment (pharmaceuticals) or treatment within last 12 months
Active COVID-19 or within the past 3 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Beyer, Ph.D.	Contact	414-955-7514		abeyer@mcw.edu
William Hughes, Ph.D.	Contact	414-955-7519		whughes@mcw.edu

Overall Officials

Name	Affiliation	Role
Andreas Beyer, Ph.D.	Associate Professor	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Data available upon record completion

Access Criteria

Not provided

URL

Not provided