Cambridge Cognition submits FDA Letter of Intent for Cognitive Impairment Assessments in Schizophrenia
Cambridge Cognition submits FDA Letter of Intent for Cognitive Impairment Assessments in Schizophrenia
Cambridge Cognition (AIM: COG), the brain health software group specialising in digital products to advance clinical research and patient treatment, has submitted a Letter of Intent to the U.S. Food and Drug Administration (FDA) under the Drug Development Tool pathway, outlining its plan to develop and validate an objective and reliable measure of cognitive impairment associated with schizophrenia (CIAS).
The FDA has indicated that CIAS improvement could serve as a co-primary outcome in schizophrenia clinical trials, alongside functional improvement1. This development aligns with the growing recognition of cognitive symptoms as a crucial treatment target in schizophrenia care.
CIAS affects functions such as memory, attention, and problem-solving in people with schizophrenia. It appears early in the illness, even before medication starts. The impairment is typically more severe than cognitive issues seen in other mental health conditions and impacts daily functioning; making it harder for patients to work, maintain relationships, and live independently. Research shows that CIAS accounts for up to 60% of functional challenges faced by patients2. Unlike other schizophrenia symptoms, CIAS tends to persist regardless of whether other symptoms are well-controlled and there is no approved treatment which targets this important symptom.
The Letter of Intent outlines Cambridge Cognition's proposed approach to digital cognitive assessment for use in clinical trials in CIAS, making use of its touch screen computerised cognitive tasks and providing scalable assessments of the core cognitive domains affected in schizophrenia, reducing some of the burden associated with lengthy and potentially less accurate pencil and paper cognitive tests. The approach builds on recent positive exploratory results using several of these assessments in a Phase III clinical trial of patients with schizophrenia3.
Rob Baker, Joint Managing Director and Chief Operating Officer, commented:
"This Letter of Intent submission to the FDA marks a pivotal moment in our strategy to address the critical need for improved cognitive assessment in schizophrenia. If approved, this holds the potential to streamline clinical trials and accelerate the development of targeted treatments. Our approach offers unique advantages in terms of sensitivity, reliability and ease of use compared to traditional cognitive assessment methods. While we are still in the early stages of this regulatory process, we are confident that our extensive scientific foundation and clinical evidence base position us well for constructive discussions with the FDA."
The Company will provide further updates as appropriate.
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