AT-001 for Long-term Preservation of Brain Health in Aging

NCT03062384 | Completed

• 1 other identifier: 15 0534 F6A
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if the use of a yeast-selenium supplement (AT-001) is safe in elderly subjects who do not have dementia, and further, to see if the supplement improves tests that are related to brain health.

Conditions

Oxidative Stress

Keywords

brain; health

Outcome Measures

Primary Outcomes (2)

• Cerebrospinal fluid Aβ42

  Baseline to End-of-Study (12 months)

• Serum levels of prostaglandins PGF2α and PGE2

  Baseline to End-of-Study (12 months)

Secondary Outcomes (6)

• Urine levels of prostaglandins PGF2α and PGE2

  Baseline to End-of-Study (12 months)

• Cerebrospinal fluid levels of phosphorylated and total tau protein

  Baseline to End-of-Study (12 months)

• Volumetric brain MRI measurements

  Baseline to End-of-Study (12 months)

• Neurocognitive measure: Free and Cued Selective Reminding Test (FCSRT)

  Baseline to End-of-Study (12 months)

• Neurocognitive measure: Trail-making test parts A and B

  Baseline to End-of-Study (12 months)

Study Arms (2)

AT-001

EXPERIMENTAL

Yeast-selenium supplement

Dietary Supplement: AT-001

Placebo

PLACEBO COMPARATOR

Yeast supplement devoid of selenium

Dietary Supplement: Placebo

Interventions

AT-001 DIETARY_SUPPLEMENT

AT-001

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Not demented by DSM-IV criteria.
• English-speaking, to ensure compliance with cognitive testing and study visit procedures.
• Montreal Cognitive Assessment (MoCA) score at screening visit ≥24/30.
• Female participants must not be pregnant or of childbearing potential (surgically sterile or post-menopausal for \>1 year).
• Stable medical condition for 3 months prior to screening visit in the opinion of the study physician.
• Non-diabetic, confirmed by fasting serum glucose \<120 mg/dL and on no oral hypoglycemic agents or insulin treatment.
• No other clinically significant abnormalities on labs (CBC, chemistry panel, PT/INR, aPTT, urinalysis).
• Stable medications for 4 weeks prior to screening.
• Able to ingest oral medications.
• Physically acceptable for the study as confirmed by medial history, physical exam, neurological exam, and clinical tests in the opinion of the study physician.

You may not qualify if:

• Significant neurological disease, such as Parkinson's disease, brain tumor, multiple sclerosis, or seizure disorder
• Major depression in the past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse.
• History of invasive cancer within the past 2 years (excluding non-melanoma skin cancer).
• Contraindications to lumbar puncture (bleeding disorder, platelet count \<100,000, anticoagulant treatment, major structural abnormality or sepsis in the area of the lumbosacral spine, or previous lower back surgery that would make LP technically difficult in the opinion of the study physician, hypersensitivity to lidocaine).
• Contraindications to MRI (pacemaker, shrapnel, metallic implants, etc).
• Clinically significant abnormalities on labs (CBC, chemistry panel, PT/INR, aPTT, urinalysis).
• Use of any investigational agents within 30 days prior to screening.
• Major surgery within eight weeks prior to the Baseline Visit.
• Severe unstable major medical illnesses, including uncontrolled cardiac conditions or heart failure (New York Heart Association Class III or IV).
• Antiretroviral therapy for human immunodeficiency virus (HIV).
• Residence in a skilled nursing facility.
• Blindness, deafness, language difficulties, or any other disability which may prevent the participant.
• Excluded Medications:
• Experimental drugs.
• Coumadin, heparin, or any other anticoagulant.

Sponsors & Collaborators

• University of Kentucky: lead
• Alltech Life Sciences Inc.: collaborator

Study Sites (1)

University of Kentucky Sanders-Brown Center on Aging Clinic

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Interventions

caficrestat

Study Officials

• Richard R Murphy, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Ronan Powers, PhD

  Alltech Life Sciences Inc.

  STUDY DIRECTOR

• Gregory A. Jicha, MD, PhD

  University of Kentucky

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.S., Assistant Professor

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: February 23, 2017
• Study Start: May 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)