LACI-Cog1

SVD is a common condition affecting the small blood vessels in the brain. It is an important cause of stroke, problems with thinking and memory, difficulties with walking and balance, and dementia. 

The medications being studied, ISMN and cilostazol, are already used safely for other conditions and are thought to improve the function of small blood vessels and the brain. LACI-Cog1 will explore whether they might also help with thinking and memory in people with mild memory and thinking problems caused by changes in the brain’s blood vessels.  

Study participants will continue their usual medical care and will be randomly allocated to receive: 

•    ISMN
•    Cilostazol
•    Both medications together
•    Neither medication (usual care only)

The study will follow participants over 8 weeks. 

•    Assess whether ISMN and cilostazol are acceptable and tolerable for people with mild thinking and memory problems due to SVD
•    Measure whether the medications have effects on memory, thinking, mood, and day-to-day function
•    Examine whether the medications influence markers of brain and blood vessel health
•    Test the practical aspects of recruitment, study visits, and assessment in this patient group
•    Help identify which outcomes should be used in a larger future trial

The funding for LACI-Cog1 will allow the research team to set up and run the study, recruit and follow-up people with mild cognitive impairment (MCI) caused by problems with the brain’s small blood vessels, and carry out detailed assessments of thinking and memory, mood, mobility, day-to-day functioning, and general health. It will also support detailed brain scans, as well as measurements of the small blood vessels in the back of the eye (the retina), which are very similar to those in the brain and may provide additional information. 

It will also allow us to collect and analyse the study data. Most importantly, it supports this as a first proof-of-concept study and will help us determine whether these medicines show enough promise within this patient population to justify a larger and longer trial in the near future. 

We plan to recruit approximately 60 participants from NHS Lothian within two years. Participants may be identified through memory clinics and existing research registers. Potential participants will first be approached by a member of their usual clinical care team, or if they have previously agreed to be contacted about research, by the research team. Recruitment is expected to begin in the coming months.  

LACI-Cog1 is intended to be the first step in a larger programme of research into treatments for mild cognitive impairment due to cerebral small vessel disease. It forms part of the existing and promising LACI trials, the most current of which is a phase 3 trial currently recruiting in several centres across the country.

At present, there are no proven treatments specifically aimed at slowing or preventing the effects of SVD on memory and thinking. If ISMN and/or cilostazol appear promising in LACI-Cog1, the results will be used to plan larger studies involving more participants and longer follow-up. Ultimately, this research aims to identify treatments that could reduce the risk of dementia, stroke, and loss of independent in people living with SVD.