← Trials/Trial dossier/NCT02045056
Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
Lead sponsor
Asset
Gemfibrozil
Listed sites
1
Recruiting sites
-
Enrollment
72
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 65-90
Primary endpoints
•Safety•MicroRNA-107 levels•Beta-amyloid levels
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Participants must meet all of the following inclusion criteria in order to participate in the study:
1. Men or women aged 65-90, inclusive.
2. 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)
3. Non-diabetic or well controlled diabetes confirmed by fasting serum glucose <126 mg/dL.
4. Stable medications for 4 weeks prior to screening visit.
5. Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
Exclusion criteria
1. Female participants that are pregnant or of childbearing potential.
2. Unstable medical conditions for three months prior to screening visit such as poorly controlled blood pressure, diabetes, or breathing problems…etc.
3. Clinically significant abnormalities on liver, kidney or other blood tests
4. Significant neurologic disease such as Alzheimer's disease, Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder.
5. 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.
6. History of invasive cancer within the past two years.
7. 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).
8. Use of any investigational agents within 30 days prior to screening.
9. Contra-indications to MRI (metallic implants, pacemaker, shrapnel, ect…)
10. Sensitivity, intolerance, or allergies to gemfibrozil or any previous reaction to any cholesterol lowering medicine.
11. Major surgery within eight weeks prior to the Baseline Visit.
12. Blindness, deafness, language difficulties or any other disability which may prevent the potential participant from participating or cooperating in the protocol.
13. Physically unacceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
Excluded Medications:
1. Experimental drugs
2. Repaglinide
3. "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.
4. 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.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Memory
2 endpointsFree and cued selective reminding test (FCSRT)
Time frame:48 weeks
descriptive
Paired associates learning (PAL)
Time frame:48 weeks
descriptive
Amyloid biomarkers
1 endpointbeta-amyloid levels
Time frame:48 weeks
descriptive
Fluid / digital biomarkers
1 endpointmicroRNA-107 levels
Time frame:48 weeks
descriptive
Safety / tolerability / PK
1 endpointSafety
Time frame:52 weeks
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.