Alzheimer DiseaseNCT02530255
Telomerase Activator and Retinal Amyloid
A study testing cycloastragenol in people with Alzheimer Disease, run by Chippewa Valley Eye Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- cycloastragenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- qualifying retinal amyloid index (RAI) number as determined at screening
- Must be able to swallow capsule
Who cannot join
- Cancer treatment within 5 years (except non-melanoma skin cancer)
- Must be able to swallow capsule
Trial locations and contacts
1 site in 1 country.
United States1 site
Chippewa Valley Eye Clinic
Eau Claire, Wisconsin, 54701
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- cycloastragenol, placebo (for cycloastragenol)
- Keywords
- retinal amyloid, Retinal amyloid index, Alzheimer disease, telomere attrition, telomere activation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cycloastragenolDietary supplement
Also called TA-65
Oral telomerase activator - cycloastragenol.
placebo (for cycloastragenol)Dietary supplement
Also called Silicone dioxide and cellulose
placebo comparator, placebo for cycloastragenol.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Study subjects receiving placebo: Intervention - two capsules, one morning and one night for one year; placebo for cycloastragenol Receives: Dietary Supplement: placebo (for cycloastragenol) |
| cycloastragenol | Active comparator | Study subjects receiving cycloastragenol: Intervention - cycloastragenol; oral capsules 8mg. per day (two capsules) one in the morning and one at night for one year. Receives: Dietary Supplement: cycloastragenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Amyloid Index (RAI)
Measurement of amyloid fluorescence while taking cycloastragalone or placebo
Measured: one year.
Secondary outcomes (1)
Telomere length (kilobases)
Telomere length measured in white blood cells isolated from saliva
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study start1 Dec 2016
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chippewa Valley Eye Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- TA-Sciences
- Responsible party
- Sponsor
- Investigators
- Coad T. Dow, M.D., Principal investigator, Chippewa Valley Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530255
- Sponsor's protocol ID
- TAS-003-AD
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25896211Koronyo 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.
PubMed 22343730Mattson 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.
PubMed 10959037Panossian 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.
PubMed 12493553Wang 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.
PubMed 25564872
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Telomerase Activator on Retinal Amyloid
- ClinicalTrials.gov ID
- NCT02530255
- Acronym / sponsor ID
- TAS-003-AD
- Conditions
- Alzheimer Disease
- Keywords
- retinal amyloid, Retinal amyloid index, Alzheimer disease, telomere attrition, telomere activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chippewa Valley Eye ClinicUniversity, hospital or other
- Collaborators
- TA-Sciences
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: placebo (for cycloastragenol)Study subjects receiving placebo: Intervention - two capsules, one morning and one night for one year; placebo for cycloastragenol |
| cycloastragenol | Active comparator | Dietary Supplement: cycloastragenolStudy subjects receiving cycloastragenol: Intervention - cycloastragenol; oral capsules 8mg. per day (two capsules) one in the morning and one at night for one year. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- qualifying retinal amyloid index (RAI) number as determined at screening
- Must be able to swallow capsule
Key exclusion criteria (2 listed)
- Cancer treatment within 5 years (except non-melanoma skin cancer)
- Must be able to swallow capsule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cycloastragenolAlso: TA-65Oral telomerase activator - cycloastragenol. | Dietary supplement | cycloastragenol |
| placebo (for cycloastragenol)Also: Silicone dioxide and celluloseplacebo comparator, placebo for cycloastragenol. | Dietary supplement | Placebo |
Primary outcome
Retinal Amyloid Index (RAI)
Time frame: one year.
Measurement of amyloid fluorescence while taking cycloastragalone or placebo
1 secondary outcome
Telomere length (kilobases)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 25896211Boccardi 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.
- Background: PubMed 22343730Koronyo 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.
- Background: PubMed 10959037Mattson 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.
- Background: PubMed 12493553Panossian 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.
- Background: PubMed 25564872Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Coad T. Dow, M.D. principal investigator
Chippewa Valley Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cycloastragenol in people with Alzheimer Disease, run by Chippewa Valley Eye Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Amyloid Index (RAI) (time frame: one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530255, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.