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CTAD 2025 | Update on the ongoing Phase III POLARIS-AD trial of mirodenafil in MCI or mild dementia due to AD

Sharon Sha, MD, MS, Stanford University Medical Center, Stanford, CA, discusses the Phase III POLARIS-AD trial (NCT05531526), which is investigating the efficacy of mirodenafil in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD). Prof. Sha highlights that the trial has reached full enrollment, with results expected in quarter three of 2026. This interview took place at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference in San Diego, CA.

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Transcript

Yeah, POLARIS-AD is using mirodenafil or AR-1001 in a large Phase III clinical trial for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Now, these participants must have biomarker confirmation of amyloid, so either CSF or a PET scan. And over 50% of the participants must have biomarker confirmation of amyloid, so either CSF or a PET scan. And over 50% of the participants who were enrolled actually contributed CSF...

Yeah, POLARIS-AD is using mirodenafil or AR-1001 in a large Phase III clinical trial for people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. Now, these participants must have biomarker confirmation of amyloid, so either CSF or a PET scan. And over 50% of the participants must have biomarker confirmation of amyloid, so either CSF or a PET scan. And over 50% of the participants who were enrolled actually contributed CSF. So it’s one of the largest biorepositories of CSF in an Alzheimer’s disease clinical trial to date. It enrolled over 1,500 participants, and it’s now fully enrolled. And the goal is really to test if this drug is efficacious against placebo. So we’re very excited that it is fully enrolled, and actually over 30% of participants have completed the 52-week treatment phase. And there is another 52-week long-term extension or open-label extension for this clinical trial. So this will be one of the largest phase three clinical trials for Alzheimer’s disease using a polypharmacologic oral drug. And we’re very excited to see the results. We expect the results to occur probably end of quarter three of 2026.

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Disclosures

Salary support from: Aribio, Biogen, Cognition Therapeutics, Eisai, Eli Lilly, EIP Pharma, Jannsen. SAB member of Cognition Therapeutics. Consulting support from: Guidepost Global, ExpertConnect.