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Telomerase Activator and Retinal Amyloid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530255
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
TA-Sciences
Information provided by (Responsible Party):
Chippewa Valley Eye Clinic

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Dietary Supplement: cycloastragenol Dietary Supplement: placebo (for cycloastragenol) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of an Oral Telomerase Activator on Retinal Amyloid
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : December 31, 2018


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 Name: 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 Name: TA-65




Primary Outcome Measures :
  1. Retinal Amyloid Index (RAI) [ Time Frame: one year. ]
    Measurement of amyloid fluorescence while taking cycloastragalone or placebo


Secondary Outcome Measures :
  1. Telomere length (kilobases) [ Time Frame: one year ]
    Telomere length measured in white blood cells isolated from saliva



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530255


Locations
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United States, Wisconsin
Chippewa Valley Eye Clinic
Eau Claire, Wisconsin, United States, 54701
Sponsors and Collaborators
Chippewa Valley Eye Clinic
TA-Sciences
Investigators
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Principal Investigator: Coad T. Dow, M.D. Chippewa Valley Eye Clinic
Publications:
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Responsible Party: Chippewa Valley Eye Clinic
ClinicalTrials.gov Identifier: NCT02530255    
Other Study ID Numbers: TAS-003-AD
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chippewa Valley Eye Clinic:
retinal amyloid
Retinal amyloid index
Alzheimer disease
telomere attrition
telomere activation
Additional relevant MeSH terms:
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Alzheimer Disease
Amyloidosis
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Proteostasis Deficiencies
Metabolic Diseases