Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease

NCT02045056 | Completed Early Phase 1 DMC

• 1 other identifier: R01AG042419
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of gemfibrozil in modulating microRNA-107 levels for the prevention of Alzheimer's disease in subjects with intact cognition and mild cognitive impairment

Conditions

Preclinical Alzheimer's Disease

Keywords

Alzheimer disease; mild cognitive impairment; normal cognition

Outcome Measures

Primary Outcomes (3)

• Safety

  Adverse events reported during the course of the trial

  52 weeks

• microRNA-107 levels

  MicroRNA-107 levels will be measured in serum and cerebrospinal fluid

  48 weeks

• beta-amyloid levels

  Beta-amyloid 1-40 and 1-42 levels will be measured in cerebrospinal fluid at baseline and at 48 weeks

  48 weeks

Secondary Outcomes (2)

• Free and cued selective reminding test (FCSRT)

  48 weeks

• Paired associates learning (PAL)

  48 weeks

Study Arms (2)

Gemfibrozil

EXPERIMENTAL

Gemfibrozil 600 mg by mouth twice daily for 48 weeks

Drug: Gemfibrozil

Sugar pill

PLACEBO COMPARATOR

Matching placebo capsule by mouth twice daily for 48 weeks

Drug: Placebo

Interventions

Gemfibrozil DRUG

Gemfibrozil

Placebo DRUG

Sugar pill

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Men or women aged 65-90, inclusive.
• Stable medical condition for three months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function defined as follows: Platelets \> 100,000, Serum creatinine ≤ 1.6 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 1.5 upper limit of normal, No clinically significant abnormalities of other laboratory studies (CBC, chemistry panel)
• Non-diabetic or well controlled diabetes confirmed by fasting serum glucose \<126 mg/dL.
• Stable medications for 4 weeks prior to screening visit.
• Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
• Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the Project Director.

You may not qualify if:

• Female participants that are pregnant or of childbearing potential.
• Unstable medical conditions for three months prior to screening visit such as poorly controlled blood pressure, diabetes, or breathing problems…etc.
• Clinically significant abnormalities on liver, kidney or other blood tests
• Significant neurologic disease such as Alzheimer's disease, Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder.
• Major depression in 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 two years.
• Contra-indications to lumbar puncture (bleeding disorder, platelet count \< 100,000, anticoagulant treatment, major structural abnormality or sepsis in the area of the lumbosacral spine that would make a lumbar puncture technically difficult).
• Use of any investigational agents within 30 days prior to screening.
• Contra-indications to MRI (metallic implants, pacemaker, shrapnel, ect…)
• Sensitivity, intolerance, or allergies to gemfibrozil or any previous reaction to any cholesterol lowering medicine.
• Major surgery within eight weeks prior to the Baseline Visit.
• Blindness, deafness, language difficulties or any other disability which may prevent the potential participant from participating or cooperating in the protocol.
• Physically unacceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
• Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the examining study physician.
• Excluded Medications:

Sponsors & Collaborators

• Gregory Jicha, 323-5550: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536-0230, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Gemfibrozil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Gregory A Jicha, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: May 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 1, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)