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CompletedPhase EARLY_1

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

Asset

Gemfibrozil

Listed sites

1

Recruiting sites

-

Enrollment

72

actual

Study population

Alzheimer’s disease

Key I/E criterion

Age 65-90

Primary endpoints

SafetyMicroRNA-107 levelsBeta-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

NCT IDNCT02045056
Org study IDR01AG042419https://reporter.nih.gov/quickSearch/R01AG042419

Timeline

Milestones

Study first posted2014-01-24estimated
Study start2014-05actual (month precision)
Primary completion2018-06-30actual
Study completion2019-06actual (month precision)
Last update posted2019-10-08actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years
Maximum age90 Years
SexAll
Healthy volunteersAccepted

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.

-Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the Project Director

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.

-Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the examining study physician.

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
Amyloid biomarkers
1
Fluid / digital biomarkers
1
Safety / tolerability / PK
1

Memory

2 endpoints
Secondary/protocol endpoint

Free and cued selective reminding test (FCSRT)

Time frame:48 weeks

descriptive

Secondary/protocol endpoint

Paired associates learning (PAL)

Time frame:48 weeks

descriptive

Amyloid biomarkers

1 endpoint
Primary/protocol endpoint

beta-amyloid levels

Time frame:48 weeks

descriptive

Fluid / digital biomarkers

1 endpoint
Primary/protocol endpoint

microRNA-107 levels

Time frame:48 weeks

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Safety

Time frame:52 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.