After a wash-out period of 14 days, subjects cross over into the other treatment arm for a further 28 days. Credit: Gerd Altmann from Pixabay.

Cognition Therapeutics has announced the completion of enrolment in the Phase II SEQUEL clinical trial (COG0202, NCT04735536) of its oral small molecule CT1812 to treat adult patients with mild-to-moderate Alzheimer’s disease.

The randomised, double-blind trial has been designed to evaluate differences in synaptic function in CT1812- versus placebo-treated participants, with the help of a quantitative electroencephalogram (qEEG) for measuring theta waves.

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The Phase II SEQUEL trial enrolled 16 adult patients with mild-to-moderate Alzheimer’s disease.

They were randomised to receive either CT1812 or a placebo once-a-day for 28 days.

After a wash-out period of 14 days, participants cross over into the other treatment arm for a further 28 days.

SEQUEL will evaluate CT1812’s safety and efficacy and measure its impact on the electrical activity in the brain, and specifically those electrical impulses in the theta band.

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Topline results from the SEQUEL trial are expected in the middle of this year.

Cognition Therapeutics chief medical officer and R&D head Anthony Caggiano said: “If we demonstrate that CT1812 treatment can normalise qEEG patterns in SEQUEL by decreasing theta power relative to placebo, it may provide evidence that we are protecting synapses from the toxicity of Aβ oligomers.”

The National Institute of Aging (NIA) of the National Institutes of Health (NIH) provided $5.3m in grant awards for the SEQUEL trial.

CT1812 is an experimental candidate and is designed to attach selectively to the sigma-2 (σ-2) receptor and displace beta amyloid (Aβ) oligomers from synapses.

It has not received approval from the US FDA or other regulatory agencies and is currently being developed for mild-to-moderate Alzheimer’s disease in the SHINE trial, and dementia with Lewy bodies in the SHIMMER study.