Could a blood pressure drug slow Alzheimer's? new trial aims to find out
NCT ID NCT06362707
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether fasudil, a drug already used in Japan and China for brain blood vessel spasms, can improve memory and brain function in people with early Alzheimer's disease. Two hundred participants will receive either fasudil or a placebo for 12 months, with regular cognitive tests and brain scans to measure effects. The goal is to see if fasudil can slow the decline in thinking skills and brain metabolism.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fasudil (a drug approved in Japan and China for vasospasms, now being tested for Alzheimer's)
- What this could lead to
- If it works, this could point toward a treatment that slows memory loss and brain decline in early Alzheimer's disease.
- What could go wrong
- This is an early Phase 2 trial with only 200 participants, so results may not apply to everyone. The drug is not yet proven for Alzheimer's, and side effects are still being studied.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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: * Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), as recently defined by the FDA (2018; Figure 2) * A significant change on a validated AD amyloid or tau biomarker (as determined either by visual reading of amyloid PET scans using any of the approved ligands, or CSF Aβ 1-42 levels or blood p-tau 217 cut-offs as determined by the clinical research laboratory) * A CDR Global rating of 0.5 or 1.0 (Morris 1993) and have an MRI scan within the past two years that has no findings inconsistent with AD * Capacity to give informed consent based on the clinical judgement of an experienced clinician * The participant needs to have a reliable study partner with regular contact (a combination of face-to-face visits and telephone contact is acceptable) who has sufficient interaction with the participant to provide meaningful input into rating scales * Age from 50 years * Fluency in Norwegian and evidence of adequate premorbid intellectual functioning * Capable of participating in all scheduled evaluations and complete all required tests * Female participants must be of non-childbearing potential or have a negative serum pregnancy test within 14 days of baseline assessments and agree to the use of effective birth control throughout their participation in the study Exclusion Criteria: * Significant cerebrovascular disease, as indicated by clinical history, neurological examination, or on MRI (including cortical infarction or deep white matter or periventricular white matter hyperintensities with a Fazekas scale score of 3 (Fazekas et al 1987). * A history of cerebrovascular bleeding or severe bleeding of the digestive tract, lungs, nose or skin * Severe renal impairment (GFR \<30) or serum creatinine or urea nitrogen values ≥3 times Upper normal limit (ULN) at screening or baseline * Moderate to severe hepatic impairment. Serum alanine transaminase (ALT) or aspartate transaminase levels ≥3 times ULN at screening or baseline * Currently poorly controlled diabetes as indicated by HbA1c values \>9 * White blood cell (WBC) values \<3.5 K/μl * History of paralytic ileus or current severe chronic constipation * Known allergy to fasudil or established systemic inflammatory disease or autoimmune disease. * Clinically significant hypotension defined by blood pressure values \<90/60 mmHg, regardless of the individual's sitting or standing position and associated with relevant clinical symptoms (e.g., tachycardia, dizziness, syncope) * Current clinically significant depression or other mental disorder likely to affect cognition or interfere with study participation * Recent (within 3 months) relevant medication changes. Participants must have been on stable anti-dementia (cholinesterase inhibitors or memantine) or anti-depressive medications for at least three months before the study * Participants using sedating drugs, if unavoidable, will be excluded from the study. However, short-acting sleep medications can be used if taken as recommended and if the participant has maintained stability on them for a minimum of 3 months prior to the start of the study * Participation in other drug trials * Currently ongoing life-threatening disease, such as metastatic cancer, advanced cardiovascular disease, advanced respiratory disease, terminal kidney disease, or advanced stages of infectious diseases * Any current or past neurological disease unrelated to Alzheimer's disease with cognitive sequelae * A Corrected QT (QTc) interval ≥ 460 milliseconds for males or ≥ 470 milliseconds for females will be considered abnormal during the ECG assessments
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Akershus Hospital:
NOT_YET_RECRUITINGOslo, Oslo, Norway
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Haraldsplass Deaconess Hospital
ENROLLING_BY_INVITATIONBergen, Vestland, Norway
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Haugesund Hospital
NOT_YET_RECRUITINGHaugesund, Rogaland, Norway
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St. Olavs Hospital:
NOT_YET_RECRUITINGTrondheim, Trøndelag, Norway
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Stavanger University Hospital
RECRUITINGStavanger, Rogaland, Norway
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University Hospital of North Norway
NOT_YET_RECRUITINGTromsø, Nordland, Norway
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