Umecrine Cognition's golexanolone reverses neuroinflammation in Parkinson's disease model.
ByAinvest
Thursday, Sep 4, 2025 2:53 am ET1min read
CGTX--
The START Study (NCT05531656) is enrolling approximately 540 participants who will be treated with zervimesine or placebo for 18 months. The study will assess cognition and executive function using validated tools such as the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales. It also aims to measure biomarker and safety findings [1].
Cognition Therapeutics' president and CEO, Lisa Ricciardi, stated that the strong enrollment pace in the START Study is due to interest from patients and investigators in the potential of a convenient, once-daily oral medication. The study is the company's largest Phase 2 trial to date and the second in Alzheimer’s disease. Previous results from the SHINE Study, which tested zervimesine in patients with mild-to-moderate Alzheimer's disease, showed that the drug slows cognitive deterioration in patients with lower levels of p-tau217 [1].
Zervimesine is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer’s disease and dementia with Lewy bodies (DLB). It targets the buildup of certain proteins in the brain, which can damage neurons and ultimately destroy them, leading to progressive loss of cognitive and motor functions [1].
The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. Cognition Therapeutics is currently conducting the Phase 2 START Study in early Alzheimer’s disease, building on the promising results from the SHINE Study [1].
The START Study is supported by an $81 million grant from the National Institute of Aging (NIA) at the National Institutes of Health (R01AG065248). The study is being conducted in collaboration with the Alzheimer’s Clinical Trials Consortium (ACTC), an NIA-funded clinical trial network of 35 leading academic sites with expertise in clinical trials in Alzheimer’s disease [1].
References:
[1] https://www.biospace.com/press-releases/cognition-therapeutics-study-of-zervimesine-ct1812-in-early-alzheimers-disease-reaches-75-enrollment-target
Umecrine Cognition, a Karolinska Development portfolio company, has published data in Frontiers in Immunology showing that its drug candidate golexanolone reverses neuroinflammation in a Parkinson's disease model. This supports golexanolone as a chronic treatment for Parkinson's disease, a neurodegenerative disorder characterized by motor and cognitive symptoms. The study suggests that golexanolone alleviates symptoms of Parkinson's disease, paving the way for its use as a chronic treatment.
Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage biopharmaceutical company focused on neurodegenerative disorders, has announced that its Phase 2 ‘START’ Study has reached the 75% enrollment mark. The study, which aims to evaluate the efficacy and tolerability of zervimesine (CT1812) in individuals with mild cognitive impairment (MCI) and early Alzheimer's disease, is being conducted in collaboration with the Alzheimer’s Clinical Trials Consortium (ACTC) and is funded by the National Institute of Aging (NIA) at the National Institutes of Health [1].The START Study (NCT05531656) is enrolling approximately 540 participants who will be treated with zervimesine or placebo for 18 months. The study will assess cognition and executive function using validated tools such as the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and ADAS-Cog rating scales. It also aims to measure biomarker and safety findings [1].
Cognition Therapeutics' president and CEO, Lisa Ricciardi, stated that the strong enrollment pace in the START Study is due to interest from patients and investigators in the potential of a convenient, once-daily oral medication. The study is the company's largest Phase 2 trial to date and the second in Alzheimer’s disease. Previous results from the SHINE Study, which tested zervimesine in patients with mild-to-moderate Alzheimer's disease, showed that the drug slows cognitive deterioration in patients with lower levels of p-tau217 [1].
Zervimesine is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer’s disease and dementia with Lewy bodies (DLB). It targets the buildup of certain proteins in the brain, which can damage neurons and ultimately destroy them, leading to progressive loss of cognitive and motor functions [1].
The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. Cognition Therapeutics is currently conducting the Phase 2 START Study in early Alzheimer’s disease, building on the promising results from the SHINE Study [1].
The START Study is supported by an $81 million grant from the National Institute of Aging (NIA) at the National Institutes of Health (R01AG065248). The study is being conducted in collaboration with the Alzheimer’s Clinical Trials Consortium (ACTC), an NIA-funded clinical trial network of 35 leading academic sites with expertise in clinical trials in Alzheimer’s disease [1].
References:
[1] https://www.biospace.com/press-releases/cognition-therapeutics-study-of-zervimesine-ct1812-in-early-alzheimers-disease-reaches-75-enrollment-target
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