Telomerase Activator and Retinal Amyloid
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Hematology |
| Therapuetic Areas: | Hematology, Neurology |
| Healthy: | No |
| Age Range: | 50 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | December 1, 2016 |
| End Date: | August 31, 2018 |
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.
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.
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.
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.
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
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