Cognition Therapeutics and the Alzheimer’s Clinical Trials Consortium (ACTC) have activated the first site for enrolling patients in the Phase II START study of CT1812 to treat early Alzheimer’s disease (AD).

The study will be carried out at around 50 sites in North America including more than 30 premier academic institutions which are part of the ACTC’s network.

Among the 50 sites, the University of Kentucky Sanders-Brown Center on Aging (SBCoA) is the first site activated for enrolment.

The placebo-controlled, randomised study intends to enrol up to 540 adults with early AD and elevated beta-amyloid (Aβ).

Patients will be randomised to receive either daily one dose of CT1812 orally or a placebo for 18 months.

Cognition president and CEO Lisa Ricciardi said: “While trials in this patient population are crucial, the long treatment period required to show a change in cognition can be overly burdensome for small biotechnology companies.

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“Without the support of the ACTC and the NIA’s $81m grant, we would likely not be in a position to offer these research participants the opportunity to test an oral once-daily medication that may slow the progression of Alzheimer’s disease.

“It is incredibly exciting and humbling to have reached the stage where patient recruitment can finally begin.”

The investigational oral small molecule CT1812 binds to neuron receptors and prevents the toxic effects caused by soluble Aβ oligomers.

So far, more than 200 healthy volunteers and adults with AD or dementia with Lewy bodies were evaluated to assess the tolerability of CT1812. It was found to be consistent throughout the development.

Mild to moderate adverse events were observed with no occurrence of deaths and treatment-related serious adverse events.