Telomerase Activator and Retinal Amyloid

Alzheimer Disease Clinical Trial

Official title:

Evaluation of an Oral Telomerase Activator on Retinal Amyloid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530255
• Other study ID #: TAS-003-AD
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2019
• Source: Chippewa Valley Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Amyloidosis

Intervention

Dietary Supplement:
• cycloastragenol
Oral telomerase activator - cycloastragenol.
• placebo (for cycloastragenol)
placebo comparator, placebo for cycloastragenol.

Locations

Country	Name	City	State
United States	Chippewa Valley Eye Clinic	Eau Claire	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Chippewa Valley Eye Clinic	TA-Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

Koronyo Y, Salumbides BC, Black KL, Koronyo-Hamaoui M. Alzheimer's disease in the retina: imaging retinal aß plaques for early diagnosis and therapy assessment. Neurodegener Dis. 2012;10(1-4):285-93. doi: 10.1159/000335154. Epub 2012 Feb 10. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal Amyloid Index (RAI)	Measurement of amyloid fluorescence while taking cycloastragalone or placebo	one year.
Secondary	Telomere length (kilobases)	Telomere length measured in white blood cells isolated from saliva	one year