NCT02530255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

July 25, 2015

Last Update Submit

July 1, 2019

Conditions

Alzheimer Disease

Keywords

retinal amyloidRetinal amyloid indexAlzheimer diseasetelomere attritiontelomere activation

Outcome Measures

Primary Outcomes (1)

  • Retinal Amyloid Index (RAI)

    Measurement of amyloid fluorescence while taking cycloastragalone or placebo

    one year.

Secondary Outcomes (1)

  • Telomere length (kilobases)

    one year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

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.

Dietary Supplement: cycloastragenol

Interventions

cycloastragenolDIETARY_SUPPLEMENT

Oral telomerase activator - cycloastragenol.

Also known as: TA-65
cycloastragenol
placebo (for cycloastragenol)DIETARY_SUPPLEMENT

placebo comparator, placebo for cycloastragenol.

Also known as: Silicone dioxide and cellulose
Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • qualifying retinal amyloid index (RAI) number as determined at screening
  • Must be able to swallow capsule

You may not qualify if:

  • Cancer treatment within 5 years (except non-melanoma skin cancer)
  • Must be able to swallow capsule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chippewa Valley Eye Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Related 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.

    PMID: 25896211BACKGROUND

  • 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.

    PMID: 22343730BACKGROUND

  • 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.

    PMID: 10959037BACKGROUND

  • 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.

    PMID: 12493553BACKGROUND

  • 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.

    PMID: 25564872BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

cycloastragenolCellulose

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Coad T. Dow, M.D.

    Chippewa Valley Eye Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2015

First Posted

August 21, 2015

Study Start

December 1, 2016

Primary Completion

October 31, 2018

Study Completion

December 31, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)