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Potassium Channel Opener

Nicorandil for Hippocampal Sclerosis (SMArT-HS Trial)

Q: How many participants are actively involved in this investigation?

Affirmative. The data hosted on clinicaltrials.gov suggests that this medical study, which was first posted on December 1st 2021, is actively recruiting volunteers for participation. There are 64 slots available from a single site.

Q: Are there any preceding experiments that have utilized Nicorandil?

Currently, there are zero Phase 3 trials for Nicorandil; however, the pharmaceutical is being tested in three separate clinical sites primarily located around Shanghai.

Q: Does this experiment have any open opportunities for volunteers?

Clinicaltrials.gov confirms that this investigation is in the process of recruiting participants, with its origin being December 1st 2021 and most recent amendment on January 9th 2022.

Q: Is Nicorandil likely to cause adverse effects in patients?

There is limited clinical evidence concerning Nicorandil's safety, subsequently granting it a score of 2.

Phase 2

Recruiting

Led By Gregory A Jicha, MD, PhD

Research Sponsored by Gregory Jicha, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

UPDRS ≤ 7

CSF profile of 'A-T-N+' defined as Aβ(1-42)>250pg/ml; Total Tau>50pg/ml; Phospho-tau<30pg/ml within 24 months, Aβ PET scan negative for Alzheimer's disease within 24 months, or plasma profile of Phospho-tau181 negative for Alzheimer's disease; hippocampal volume ≤ 1 s.d. below age and gender adjusted mean

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 weeks

Awards & highlights

SMArT-HS Trial Summary

This trial seeks to find a potential treatment for Hippocampal Sclerosis of Aging, a disease which is often mistaken for Alzheimer's Disease. This study could help alleviate the burden on the elderly population suffering from dementia.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the side effects are not explicitly listed here, common ones for Nicorandil may include headaches, dizziness, nausea or weakness. As it's used for heart-related conditions too, participants on certain heart medications are excluded due to potential adverse interactions.

SMArT-HS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My Parkinson's symptoms are mild.

Select...

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

Select...

I am 75 years old or older.

Select...

I can take pills by mouth.

SMArT-HS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of subjects by arm that experience treatment-related adverse events at week 96

Secondary outcome measures

Hippocampal volume (CC)

Side effects data

From 2014 Phase 4 trial • 402 Patients • NCT01396395

Headache

Nausea

Glaucoma

Chest pain

Gastric ulcer

Peripheral edema

Dizziness

Coronary artery disease

Angina

Diabetic foot

Multiple myeloma

Sudden death

Unstable angina

Supraventricular tachycardia

Duodenal ulcer

Chronic renal failure

Increased blood pressure

100%

80%

60%

40%

20%

Study treatment Arm

Standard Treatment Plus Nicorandil

Standard Treatment

SMArT-HS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Nicorandil 20mg qd

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo qd

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicorandil

2018

Completed Phase 4

~840

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gregory Jicha, MD, PhDLead Sponsor

National Institute on Aging (NIA)NIH

1,676 Previous Clinical Trials

28,021,435 Total Patients Enrolled

Gregory A Jicha, MD, PhDPrincipal InvestigatorUniversity of Kentucky

3 Previous Clinical Trials

141 Total Patients Enrolled

Media Library

Mild Cognitive Impairment Research Study Groups: Treatment, Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively involved in this investigation?

"Affirmative. The data hosted on clinicaltrials.gov suggests that this medical study, which was first posted on December 1st 2021, is actively recruiting volunteers for participation. There are 64 slots available from a single site."

Answered by AI

Are there any preceding experiments that have utilized Nicorandil?

"Currently, there are zero Phase 3 trials for Nicorandil; however, the pharmaceutical is being tested in three separate clinical sites primarily located around Shanghai."

Answered by AI

Does this experiment have any open opportunities for volunteers?

"Clinicaltrials.gov confirms that this investigation is in the process of recruiting participants, with its origin being December 1st 2021 and most recent amendment on January 9th 2022."

Answered by AI