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Completed

NCT Number: NCT02530255

Telomerase Activator and 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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chippewa Valley Eye Clinic

Eau Claire, Wisconsin, 54701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cycloastragenol

Dietary Supplement

Oral telomerase activator - cycloastragenol.

Other names: TA-65

placebo (for cycloastragenol)

Dietary Supplement

placebo comparator, placebo for cycloastragenol.

Other names: Silicone dioxide and cellulose

Primary outcomes

  1. Retinal Amyloid Index (RAI)

    Time frame: one year.

    Measurement of amyloid fluorescence while taking cycloastragalone or placebo

Secondary outcomes

  1. Telomere length (kilobases)

    Time frame: one year

    Telomere length measured in white blood cells isolated from saliva

Sponsors and collaborators

Lead sponsor

Chippewa Valley Eye Clinic

Other

Collaborators

  • TA-Sciences

Registry information

Official study title

Evaluation of an Oral Telomerase Activator on Retinal Amyloid

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2015
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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