Telomerase Activator and Retinal Amyloid
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Amyloidosis
Study type: Interventional

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.
    

Intervention name(s): cycloastragenol; placebo (for cycloastragenol)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral telomerase activator - cycloastragenol.; placebo comparator, placebo for cycloastragenol.
Other intervention name(s): TA-65; Silicone dioxide and cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: retinal amyloid; Retinal amyloid index; Alzheimer disease; telomere attrition; telomere activation