Arctic Therapeutics Receives EMA Approval for Phase IIa Study of AT-001 in Alzheimer's Disease

"Alzheimer's disease is one of the world's most urgent healthcare challenges. Advances in early diagnosis, combined with treatments that enable earlier intervention, hold the potential to transform how we approach Alzheimer's, as well as other forms of dementia," ATx founder Dr. Hakon Hakonarson said. "Through our clinical trials targeting both rare and common forms of dementia, we are pushing the science forward with the goal of not only delaying progression, but ultimately preventing these diseases altogether," Dr. Hakonarson added.

Iceland, 03/11/2025 (informazione.news - comunicati stampa - salute e benessere)

ATx founder Dr. Hakon Hakonarson said. Dr. Hakonarson added

The study authorisation in AD follows the EMA's authorisation last year for ATx to initiate a Phase IIb/III study of AT-001 in HCCAA, an ultra-rare condition marked by amyloid buildup in the brain's blood vessels that can cause cerebral haemorrhage, stroke and progressive neurological decline, including dementia. In addition, the EMA has granted AT-001 ODD for the treatment of HCCAA, a form of hereditary cerebral amyloid angiopathy (CAA).

," CEO and co-founder Ivar Hakonarson said

The study will evaluate the safety, tolerability, and biomarker-based efficacy of AT-001, a small molecule oral therapy, in patients aged 50-85 with mild cognitive impairment (MCI) or mild Alzheimer's disease. The study will be a multicentre, randomized, double-blind, placebo-controlled trial conducted at four sites across Denmark and Iceland in collaboration with Sanos Group, a global multi-niche CRO.

The trial will enrol patients for 12 months of treatment with escalating oral doses of AT-001. Safety labs will be monitored monthly, together with biomarker assessments every three months, MRI at baseline, mid- and end of study, and PET scans at baseline and study completion.

The study's primary focus is on safety and biomarker efficacy. Selected biomarkers include: 

Upon completion of the trial the biomarker/brain amyloid results will be analysed in the context of clinical improvement observed with recent monoclonal antibody-based amyloid reduction therapies.

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