Telomerase Activator and Retinal Amyloid

Chippewa Valley Eye Clinic

Status: Completed

Conditions: Alzheimer Disease

Treatments: Dietary Supplement: cycloastragenol; Dietary Supplement: placebo (for cycloastragenol)

Study type: Interventional

Funder types: Other

Identifiers

NCT02530255

TAS-003-AD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Study subjects receiving placebo: Intervention - two capsules, one morning and one night for one year; placebo for cycloastragenol

Treatment:

Dietary Supplement: placebo (for cycloastragenol)

cycloastragenol

Active Comparator group

Description:

Study subjects receiving cycloastragenol: Intervention - cycloastragenol; oral capsules 8mg. per day (two capsules) one in the morning and one at night for one year.

Treatment:

Dietary Supplement: cycloastragenol