Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2016-12-01
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigating the Effect of Vitamin A Supplementation on Retinitis Pigmentosa
NCT00065455
Effects of Lutein in Retinitis Pigmentosa
NCT00029289
Alpha Lipoic Acid in Geographic Atrophy
NCT02613572
Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation
NCT02264938
Effects of Antioxidants on Human Macular Pigments
NCT00718653
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Study subjects receiving placebo: Intervention - two capsules, one morning and one night for one year; placebo for cycloastragenol
placebo (for cycloastragenol)
placebo comparator, placebo for cycloastragenol.
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.
cycloastragenol
Oral telomerase activator - cycloastragenol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cycloastragenol
Oral telomerase activator - cycloastragenol.
placebo (for cycloastragenol)
placebo comparator, placebo for cycloastragenol.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be able to swallow capsule
Exclusion Criteria
* Must be able to swallow capsule
50 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TA-Sciences
UNKNOWN
Chippewa Valley Eye Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Coad T. Dow, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chippewa Valley Eye Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chippewa Valley Eye Clinic
Eau Claire, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TAS-003-AD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.