Down Syndrome Lithium Trial (DownsLit) v1.1

• Research type

  Research Study

• Full title

  Genetically determined brain abnormalities in Down syndrome – towards a treatment : A single blind placebo controlled trial of lithium carbonate in Down Syndrome

• IRAS ID

  11900

• Contact name

  Giles Tan

• Sponsor organisation

  King's College London (IOP)

• Eudract number

  2008-008342-20

• ISRCTN Number

  N/A

• Research summary

  People with Down Syndrome have a learning disability (mental retardation), and eventually develop the pathology of Alzheimer??s Disease in their brains. The reason for this devastating Ó?double hit? is unknown. However, we recently found that a brain chemical called myo-inositol is significantly increased in non-demented Down Syndrome adults, and explains a significant proportion of their learning disability. Myo-inositol also causes the pathology of Alzheimer??s disease in both animal, and test tube, models. We recently found that dementia in Down Syndrome was associated with an increase in myo-inositol compared with Alzheimer's Disease in the general population and also with further increases in myo-inositol compared with Down Syndrome without dementia. Therefore, elevated myo-inositol may thus also be a pathological Ó?tipping point? into early dementia in Down Syndrome. Previous studies of lithium, a medicine that has long been used to treat mood disorders and challenging behaviours, have shown that it reduces myo-inositol in the brain. However, these studies were done in the general population and not in people with Down Syndrome. Hence, we need to know if myo-inositol can be reduced in the brains of people with Down Syndrome. We will do this using a non-invasive brain imaging technique called magnetic resonance spectroscopy to measure myo-inositol in the brains of people with Down Syndrome following a brief treatment with lithium. If successful, this work will form the basis of future treatment trials to both improve cognitive function and reduce the risk for developing Alzheimer??s disease in Down Syndrome.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/3

• Date of REC Opinion

  23 Feb 2009

• REC opinion

  Further Information Favourable Opinion