Telomerase Activator and Retinal Amyloid

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Evaluation of an Oral Telomerase Activator on Retinal Amyloid

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Dietary Supplement: cycloastragenol
* Dietary Supplement: placebo (for cycloastragenol)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Study subjects receiving placebo: Intervention - two capsules, one morning and one night for one year; placebo for cycloastragenol | Dietary Supplement: placebo (for cycloastragenol)<br>* placebo comparator, placebo for cycloastragenol.<br>* Other names: Silicone dioxide and cellulose;|
| Active Comparator: cycloastragenol<br>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<br>* Oral telomerase activator - cycloastragenol.<br>* Other names: TA-65;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal amyloid, Retinal amyloid index, Alzheimer disease, telomere attrition, telomere activation