Nicorandil for Hippocampal Sclerosis (SMArT-HS Trial)

Recruiting in Palo Alto (17 mi)

Gregory A. Jicha, MD, PhD | UK Healthcare

Overseen ByGregory A Jicha, MD, PhD

Age: 65+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gregory Jicha, MD, PhD

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing nicorandil, a heart medication, to see if it can help elderly patients with Hippocampal Sclerosis of Aging (HS-Aging), a condition often mistaken for Alzheimer's disease. HS-Aging affects many older adults and currently has no specific treatments. Nicorandil may help by improving blood flow, potentially reducing symptoms of dementia. Nicorandil has shown potential as a therapeutic agent for Alzheimer's disease by inhibiting oxidative stress and amyloid-β precursor protein processing.

Eligibility Criteria

This trial is for English-speaking men and women aged 75 or older with cognitive impairment but not Alzheimer's. They must have a stable medical condition, no recent severe illnesses, cancer history (with exceptions), or major surgeries. Participants need a study partner to help with medication and visits, be able to take oral meds, and have specific CSF profiles or brain scans.

Inclusion Criteria

My Parkinson's symptoms are mild.

My tests show I might not have Alzheimer's based on specific protein levels and brain scans.

I am 75 years old or older.

I can take pills by mouth.

Exclusion Criteria

I am not taking experimental drugs, vasoactive nitrates, erectile dysfunction medication, or sulfonylurea antidiabetic agents.

I have not had major surgery in the last 8 weeks.

I have been diagnosed with major depression in the last year.

I have a serious neurological condition like Parkinson's, stroke, brain tumor, MS, or seizures.

I do not have any disabilities that would stop me from following the study's requirements.

I do not have severe heart problems or uncontrolled illnesses.

Participant Groups

The trial tests Nicorandil against a placebo in treating Hippocampal Sclerosis of Aging—a dementia mimic without current treatments. It explores repurposing an existing drug to modulate ABCC9 pathways as a novel approach to alleviate late-life dementia symptoms.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Nicorandil 20mg qd

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo qd