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Telomerase Activator and Retinal Amyloid

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cycloastragenol
placebo (for cycloastragenol)
Sponsored by
Chippewa Valley Eye Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring retinal amyloid, Retinal amyloid index, Alzheimer disease, telomere attrition, telomere activation

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Chippewa Valley Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

cycloastragenol

Arm Description

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

Outcomes

Primary Outcome Measures

Retinal Amyloid Index (RAI)
Measurement of amyloid fluorescence while taking cycloastragalone or placebo

Secondary Outcome Measures

Telomere length (kilobases)
Telomere length measured in white blood cells isolated from saliva

Full Information

First Posted
July 25, 2015
Last Updated
July 1, 2019
Sponsor
Chippewa Valley Eye Clinic
Collaborators
TA-Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02530255
Brief Title
Telomerase Activator and Retinal Amyloid
Official Title
Evaluation of an Oral Telomerase Activator on Retinal Amyloid
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chippewa Valley Eye Clinic
Collaborators
TA-Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
retinal amyloid, Retinal amyloid index, Alzheimer disease, telomere attrition, telomere activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study subjects receiving placebo: Intervention - two capsules, one morning and one night for one year; placebo for cycloastragenol
Arm Title
cycloastragenol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
cycloastragenol
Other Intervention Name(s)
TA-65
Intervention Description
Oral telomerase activator - cycloastragenol.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo (for cycloastragenol)
Other Intervention Name(s)
Silicone dioxide and cellulose
Intervention Description
placebo comparator, placebo for cycloastragenol.
Primary Outcome Measure Information:
Title
Retinal Amyloid Index (RAI)
Description
Measurement of amyloid fluorescence while taking cycloastragalone or placebo
Time Frame
one year.
Secondary Outcome Measure Information:
Title
Telomere length (kilobases)
Description
Telomere length measured in white blood cells isolated from saliva
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coad T. Dow, M.D.
Organizational Affiliation
Chippewa Valley Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chippewa Valley Eye Clinic
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25896211
Citation
Boccardi V, Pelini L, Ercolani S, Ruggiero C, Mecocci P. From cellular senescence to Alzheimer's disease: The role of telomere shortening. Ageing Res Rev. 2015 Jul;22:1-8. doi: 10.1016/j.arr.2015.04.003. Epub 2015 Apr 17.
Results Reference
background
PubMed Identifier
22343730
Citation
Koronyo Y, Salumbides BC, Black KL, Koronyo-Hamaoui M. Alzheimer's disease in the retina: imaging retinal abeta plaques for early diagnosis and therapy assessment. Neurodegener Dis. 2012;10(1-4):285-93. doi: 10.1159/000335154. Epub 2012 Feb 10.
Results Reference
background
PubMed Identifier
10959037
Citation
Mattson MP. Emerging neuroprotective strategies for Alzheimer's disease: dietary restriction, telomerase activation, and stem cell therapy. Exp Gerontol. 2000 Jul;35(4):489-502. doi: 10.1016/s0531-5565(00)00115-7.
Results Reference
background
PubMed Identifier
12493553
Citation
Panossian LA, Porter VR, Valenzuela HF, Zhu X, Reback E, Masterman D, Cummings JL, Effros RB. Telomere shortening in T cells correlates with Alzheimer's disease status. Neurobiol Aging. 2003 Jan-Feb;24(1):77-84. doi: 10.1016/s0197-4580(02)00043-x.
Results Reference
background
PubMed Identifier
25564872
Citation
Wang J, Zhao C, Zhao A, Li M, Ren J, Qu X. New insights in amyloid beta interactions with human telomerase. J Am Chem Soc. 2015 Jan 28;137(3):1213-9. doi: 10.1021/ja511030s. Epub 2015 Jan 17.
Results Reference
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Telomerase Activator and Retinal Amyloid

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