Preclinical Alzheimer's DiseaseEarly Phase 1NCT02045056
Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
A Early Phase 1 study testing Gemfibrozil in people with Preclinical Alzheimer's Disease, run by Gregory Jicha, 323-5550 at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Preclinical Alzheimer's Disease
- What is being tested?
- Gemfibrozil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jun 2019
- Phase
- Early Phase 1
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria in order to participate in the study:
- 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.
Who cannot join
- 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.
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- 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:
- Experimental drugs
- Repaglinide
- "Statins" including but not limited to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), or any combination medicines containing these drugs.
- Coumadin, warfarin, heparin, lovenox, Xarelto, apixaban or other anticoagulants. (Antiplatelet therapy is acceptable).
- NOTE: If these drugs are discontinued 4 weeks or more before screening, then the participant can be eligible for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky
Lexington, Kentucky, 40536-0230
About this study
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
Read the detailed description
Double-blind, placebo controlled, parallel-design. 48 cognitively-intact subjects, and 24 subjects with early cognitive decline (CDR 0.5) will be randomly assigned to treatment with gemfibrozil (600 mg orally twice a day) or placebo for 52 weeks. Safety assessments will include routine assessment of adverse events, safety labs, and brain magnetic resonance imaging.
- Conditions
- Preclinical Alzheimer's Disease
- Being tested
- Gemfibrozil, Placebo
- Keywords
- Alzheimer disease, mild cognitive impairment, normal cognition
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemfibrozilDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemfibrozil | Experimental | Gemfibrozil 600 mg by mouth twice daily for 48 weeks Receives: Drug: Gemfibrozil |
| Sugar pill | Placebo comparator | Matching placebo capsule by mouth twice daily for 48 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events reported during the course of the trial
Measured: 52 weeks
microRNA-107 levels
MicroRNA-107 levels will be measured in serum and cerebrospinal fluid
Measured: 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
Measured: 48 weeks
Secondary outcomes (2)
Free and cued selective reminding test (FCSRT)
The FCSRT is a sensitive measure of memory performance that will be measured at baseline and after 48 weeks of gemfibrozil treatment
Measured: 48 weeks
Paired associates learning (PAL)
The PAL is a sensitive, computerized measure of memory performance that will be measured at baseline and after 48 weeks of gemfibrozil treatment
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startMay 2014
- Primary completion30 Jun 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preclinical Alzheimer's 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gregory Jicha, 323-5550
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gregory Jicha, 323-5550, University of Kentucky
- Investigators
- Gregory A Jicha, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045056
- Sponsor's protocol ID
- R01AG042419
- Status last verified
- Oct 2019
- First submitted
- 22 Jan 2014
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
- ClinicalTrials.gov ID
- NCT02045056
- Acronym / sponsor ID
- R01AG042419
- Conditions
- Preclinical Alzheimer's Disease
- Keywords
- Alzheimer disease, mild cognitive impairment, normal cognition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gregory Jicha, 323-5550University, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 24 Jan 2014 (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.
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
Detailed description
Double-blind, placebo controlled, parallel-design. 48 cognitively-intact subjects, and 24 subjects with early cognitive decline (CDR 0.5) will be randomly assigned to treatment with gemfibrozil (600 mg orally twice a day) or placebo for 52 weeks. Safety assessments will include routine assessment of adverse events, safety labs, and brain magnetic resonance imaging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemfibrozil | Experimental | Drug: GemfibrozilGemfibrozil 600 mg by mouth twice daily for 48 weeks |
| Sugar pill | Placebo comparator | Drug: PlaceboMatching placebo capsule by mouth twice daily for 48 weeks |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Participants must meet all of the following inclusion criteria in order to participate in the study:
- 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| Gemfibrozil | Drug | Gemfibrozil |
| Placebo | Drug | Sugar pill |
Primary outcome
Safety
Time frame: 52 weeks
Adverse events reported during the course of the trial
microRNA-107 levels
Time frame: 48 weeks
MicroRNA-107 levels will be measured in serum and cerebrospinal fluid
beta-amyloid levels
Time frame: 48 weeks
Beta-amyloid 1-40 and 1-42 levels will be measured in cerebrospinal fluid at baseline and at 48 weeks
2 secondary outcomes
Free and cued selective reminding test (FCSRT)
Time frame: 48 weeks
Paired associates learning (PAL)
Time frame: 48 weeks
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 8 Oct 2019.
- 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.
Gregory A Jicha, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gemfibrozil in people with Preclinical Alzheimer's Disease, run by Gregory Jicha, 323-5550 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 7 inclusion and 20 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 8 Oct 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.