Telomerase Activator and Retinal Amyloid

July 1, 2019 updated by: Chippewa Valley Eye Clinic

Evaluation of an Oral Telomerase Activator on Retinal Amyloid

A method of detecting amyloid in the retina has been developed. A specially designed retinal camera will directly visualze and record retinal amyloid and via image processing will generate a number: the retinal amyloid index (RAI). The amount of retinal amyloid correlates with cerebral amyloid and has a predictive value in Alzheimer's disease.

Telomere attrition accounts for cellular aging and is felt to have a pivotal role in Alzheimer's disease. The investigators plan to screen individuals to select those having retinal amyloid then evaluate an oral telomerase activator to determine if its use can alter the RAI over time compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Telomerase Activation - Retinal Amyloid Study

Telomere attrition has been linked to the neurodegenerative disease Alzheimer's disease (AD). AD is definitively diagnosed at autopsy a fact that has prompted exhaustive investigations looking for reliable biomarkers of AD. It is known that the clinical signs of AD are the end result of years of accumulation of an aggregated protein substance, amyloid. The retina is part of the brain and recently, a diagnostic technology has been developed that allows detection of retinal amyloid. Tissue studies show a correlation between retinal and cerebral amyloid, and it has been proposed that early detection of retinal amyloid, long before clinical dementia, may offer an opportunity for intervention to slow or halt progressive amyloid deposition. Special imaging technology has been developed that is capable of detecting retinal amyloid via an adapted retinal camera. Neurovision Imaging (NVI) is the company that has developed these testing technologies: both for retinal amyloid detection and measurement.

A study is proposed that will investigate if there is a measurable treatment effect of the telomerase activator TA-65 on retinal amyloid of the participants. It is anticipated that recruiting will primarily be directed at adult children of individuals with clinical AD.

The study will include 50 participants and will have a term of 12 months; it is anticipated that up to 300 individuals will be screened to acquire the participants. The study will be conducted at a single site: Chippewa Valley Eye Clinic, Eau Claire, Wisconsin and/or its satellites. TA-Sciences will sponsor the study, provide telomere length testing on saliva samples collected at the start and conclusion of study. TA-Sciences will also provide active and placebo product for term of study.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
        • Chippewa Valley Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • qualifying retinal amyloid index (RAI) number as determined at screening
  • Must be able to swallow capsule

Exclusion Criteria:

  • Cancer treatment within 5 years (except non-melanoma skin cancer)
  • Must be able to swallow capsule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Study subjects receiving placebo: Intervention - two capsules, one morning and one night for one year; placebo for cycloastragenol
Dietary supplement: placebo (for cycloastragenol)
placebo comparator, placebo for cycloastragenol.
Other Names:
  • Silicone dioxide and cellulose
Active Comparator: cycloastragenol
Study subjects receiving cycloastragenol: Intervention - cycloastragenol; oral capsules 8mg. per day (two capsules) one in the morning and one at night for one year.
Dietary supplement: cycloastragenol
Oral telomerase activator - cycloastragenol.
Other Names:
  • TA-65

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Amyloid Index (RAI)
Time Frame: one year.
Measurement of amyloid fluorescence while taking cycloastragalone or placebo
one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telomere length (kilobases)
Time Frame: one year
Telomere length measured in white blood cells isolated from saliva
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chippewa Valley Eye Clinic

Collaborators

TA-Sciences

Investigators

  • Principal Investigator: Coad T. Dow, M.D., Chippewa Valley Eye Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 25, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAS-003-AD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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