Children that are born before the 37th week of pregnancy remain under close medical supervision while they are young. Any cognitive limitations often disappear after a few years. However, children who come into the world even before the 32nd week of gestation still exhibit differences even into their teenage years. In a new study, researchers led by Dr. Sebastian Ludyga and Professor Uwe Pühse have demonstrated that these children have weaker impulse control compared with children born at term (after the 37th week of pregnancy). This can, for example, have disadvantages in school performance and is linked to behavioral problems and a higher susceptibility to addiction.

As the research team reports in the journal Developmental Cognitive Neuroscience, these differences in impulse control can be fully explained by the children’s motor skills. “In other words, premature children who had very well-developed motor skills were practically equal to children born at term when it came to impulse control,” explains Ludyga.

In their study, the researchers compared a group of 54 very preterm children aged 9 to 13 years with a control group of children of the same age who had been born at term. To test impulse control, the sports scientists conducted a “go/no go” test with the children. When given a signal, the young study participants had to push a button as quickly as possible. When given a different signal, they were not allowed to push the button – in other words, they had to suppress their impulse to move.

During the experiment, the researchers monitored certain brain activity parameters using an EEG (electroencephalogram) to determine how the children processed the stimulus. A comparison of the two groups showed that on average, the premature children found it more difficult to suppress the impulse to move due to impaired attention processes.

In further experiments, the researchers tested gross and fine motor skills, as well as ball handling. They found that the greater the deficit in motor skills, the more limited the impulse control in the children born very preterm.

“We conclude from these findings that targeted motor skills training could also reduce cognitive limitations,” explains Ludyga. The researchers now want to test this in a follow-up study.

Ludyga says that there are few support options for very premature children as they grow into teenagers unless they come under scrutiny for a different reason, such as ADHD or another illness: “Limited impulse control at this age, even if it sorts itself out later, can have negative consequences and restrict these children’s educational opportunities.”

In younger children in particular, the development of motor and cognitive skills are closely linked. The time window from 9 to 13 years is therefore a promising period in which to reduce cognitive deficits in children born very preterm.

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“These results offer hope for patients with fragile X syndrome and their families,” said Elizabeth Berry-Kravis, MD, PhD, a paediatric neurologist at Rush University Medical Centre and principal investigator of the study. “The majority of clinical outcome measures were in favour of the drug. These measures included performance-based assessments, biomarkers, and parent and physician-rated scales, which in combination, suggest a meaningful impact on the global FXS disease process.”

The study was a phase two clinical trial to assess the safety and efficacy of a drug known as BPN14770 in 30 men with between the ages of 18 and 41 years who have fragile X syndrome. BPN1477 inhibits the activity of an enzyme known as phosphodiesterase-4D (PDE4D), which controls the availability in the brain of cyclic adenosine monophosphate (cAMP), a molecule that is critically involved in memory formation. By inhibiting PDE4D, the drug increases the levels of cAMP in the brain. “It’s exciting that we have a drug that potentially addresses a core biochemical deficit in FXS, a deficiency of cAMP, that has been documented in patients, and which I discovered during my paediatric neurology fellowship 30 years ago,” Berry-Kravis said.

Participants in the study received daily oral doses of BPN14770 twice a day or a placebo for 12 weeks. Parents, caregivers and physician raters were kept unaware of whether the participants received the treatment or the placebo.

The study evaluated the participants using a version of the National Institutes of Health (NIH) Toolbox Cognitive Battery (a cognitive measure) that, in work performed in collaboration with Dr. David Hessl at the UC Davis MIND Institute, was modified to be effective in assessing people with intellectual disabilities. In addition, the study included scales on which parents’ rated improvements from the drug.

“This is the first time that the NIH Toolbox has been able to be used to demonstrate a cognitive change in a trial in people with intellectual disabilities,” Berry-Kravis said. “In just three months, we saw improvement specifically in the verbal subtests of the NIH Toolbox, coupled with parent rating of improvements, particularly in language.”

Cognitive assessments using the NIH Toolbox revealed significant benefit in oral reading recognition, picture vocabulary and the cognition crystallized composite score. Parent/caregiver ratings revealed benefit that was judged to be clinically significant in language and daily functioning.

After 12 weeks of treatment in the study, patients crossed over and took placebo if they had been taking drug, and drug if they had been taking placebo for another 12 weeks. The benefit of BPN14770 was found to persist up to 12 weeks after the crossover from drug to placebo. BPN14770 was very well tolerated, with few adverse events.

In laboratory studies, BPN14770 promoted the maturation of connections between neurons, (which is impaired in patients with fragile X syndrome). BPN14770 is being developed by Tetra Therapeutics for the treatment of fragile X syndrome. The drug’s mechanism of action also may have potential to improve cognitive and memory function in Alzheimer’s disease and other dementias, learning/developmental disabilities and schizophrenia. At this time, however, the U.S. Food and Drug Administration only has approved BPN14770 for investigational use, and it will be important to do larger controlled studies in fragile X syndrome to confirm the cognitive benefit of the drug.

Reference: Rush University Medical Centre. “Treatment found to improve cognitive function in patients with fragile X syndrome: Results from phase two study show improved language and daily functioning among participants.” ScienceDaily. ScienceDaily, 29 April 2021. www.sciencedaily.com/releases/2021/04/210429142643.htm

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“We’ve revealed the promising new potential for a safe and widely used medication, which could be life-changing for patients at risk of dementia and their families. For those with type 2 diabetes, metformin may add something extra to standard glucose lowering in diabetes care: a benefit for cognitive health,” said lead author Professor Katherine Samaras, Leader of the Healthy Ageing Research Theme at the Garvan Institute and endocrinologist at St Vincent’s Hospital in Sydney, Australia.

In this prospective, observational study, the investigators enrolled 1,037 community-dwelling subjects without dementia and aged 70–90 years at baseline in the Sydney Memory and Ageing Study.

The investigators excluded person who had been diagnosed with dementia, major neurological or psychiatric disease, or progressive malignancy.

Of the 1,037 subjects, 123 were diagnosed with Type 2 diabetes and, 67 subsequently received metformin treatment.

The investigators used standard neuropsychological tests to measure cognitive function at baseline and every 2 years. The tests included individual measures of executive function, memory, attention/speed, language, and visuospatial function.

“These [tests] were used to determine the measure of global cognition. Incident dementia was ascertained by a multidisciplinary panel,” the authors noted.

The researchers measured total brain, hippocampal, and parahippocampal volumes MRI at baseline and 2 years (n = 526).

They used standard statistical tools to measure changes in cognition and adjust for the covariates of age, sex, education, BMI, heart disease, hypertension, stroke, smoking, and apolipoprotein Eε4 carriage.

Subjects with Type 2 diabetes who were treated with metformin achieved significantly slower global cognition and executive function decline compared with those who did not receive the drug.

Notably, development of dementia was significantly higher in the subjects who did not receive metformin compared to those who did. (P = 0.05).

“This study has provided promising initial evidence that metformin may protect against cognitive decline. While type 2 diabetes is thought to increase dementia risk by promoting degenerative pathways in the brain and nerves, these pathways also occur in others at risk of dementia and it is possible insulin resistance may be the mediator,” Samaras said.

The authors concluded, “Older people with diabetes receiving metformin have slower cognitive decline and lower dementia risk. Large randomized studies in people with and without diabetes will determine whether these associations can be attributed to metformin.”

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