Could a heart pill slow a hidden dementia?
NCT ID NCT04120766
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether nicorandil, a drug currently used for heart conditions, can help people with a type of dementia called hippocampal sclerosis of aging. This condition is often mistaken for Alzheimer's but has no approved treatments. The trial includes 64 older adults and will measure safety and changes in brain volume over 96 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nicorandil (a drug used for heart conditions, repurposed here)
- What this could lead to
- If it works, this could point toward a treatment for a common but often overlooked cause of dementia that currently has no therapies.
- What could go wrong
- This is a small, early-phase trial with only 64 participants. The drug may not slow the disease or could cause side effects. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
64 people
The number who actually took part.
- Started
-
Dec 2021
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
70 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men or women at least age 75 years 2. UPDRS ≤ 7 3. Hachinski Ischemic Score ≤ 4 4. 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. Plasma ptau181 levels below 3.0 pg/ml. 5. English-speaking, to ensure compliance with cognitive testing and study visit procedures 6. Involvement of a study partner to supervise medications and compliance with study visits/procedure 7. Stable medical conditions for three months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function defined in the opinion of the investigator 8. Stable medications for 4 weeks prior to screening visit 9. Ability to ingest oral medications 10. Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests. Exclusion Criteria: 1. Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder 2. Major depression in past 12 months (DSM-IV criteria) 3. Recent (in past 12 months) substance abuse 4. History of cancer within the past two years, with the exception of non-metastatic prostate or non-melanoma skin cancers such as squamous cell and basal cell carcinomas 5. Contra-indications to lumbar puncture (bleeding disorder, platelet count \< 100,000, anticoagulant treatment, major abnormality of the spine that would make LP technically difficult) will exclude the participant from engaging in this optional procedure, but the participant may still participate in the main study using plasma p-tau181 and/or amyloid-PET for Alzheimer's disease screening 6. Use of any investigational agents within 30 days prior to screening 7. Major surgery within eight weeks prior to the Baseline Visit 8. Severe unstable medical illnesses, including uncontrolled cardiac conditions or heart failure (New York Heart Association Class III or IV) 9. Blindness, deafness, or any other disability which may prevent the participant from participating or cooperating in the protocol. Excluded Medications\* Participants are not eligible for participation in the study if they are taking: 1. Experimental drugs 2. Vasoactive nitrates such as isosorbide dinitrate 3. Drugs for erectile dysfunction such as sildenafil, vardenafil, and tadalafil among others 4. Sulfonylurea antidiabetic agents that may confound efficacy measures for the secondary efficacy outcome measures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Kentucky
Lexington, Kentucky, 40504, United States
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