Genetically determined brain abnormalities in Down's syndrome - towards a treatment: Down's syndrome Lithium Trial

Not Applicable

Completed

• Conditions: Down's syndrome; Not Applicable

• Registration Number: ISRCTN03784241
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-19
• Study Completion: 2011-12-31
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Individuals with Down's syndrome
2. Over the age of 18 years, either sex
3. Able to provide informed consent for themselves or have a representative to provide proxy consent on their behalf if they lack capacity
4. Able to communicate with the investigator and to comply with requirements of the study
5. Has carer support

Exclusion Criteria

1. Individuals with contraindications to lithium treatment
2. Individuals with contraindications to undergoing a magnetic resonance scan
3. Non-compliance with taking of the tablets between baseline and the final assessment
4. Treatment with lithium within the last 6 months
5. Evidence of dementia
6. Evidence of renal, thyroid or cardiac disease that would contraindicate taking lithium
7. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain myo-inositol concentrations (dorsolateral prefrontal cortex [DLPFC] and hippocampus) measured by 1H magnetic resonance spectroscopy (MRS) at baseline and after 4 weeks maintenance lithium treatment at therapeutic dose.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Blood biomarkers which have been implicated in the development of Alzheimer's disease:<br> 1.1. Isolation of genomic DNA for studies of genotype in relation to response including the Tau haplotype, Intron 7 repeat of APP, and ApoE4<br> 1.2. Abeta1-40, Abeta1-42 base fragments and other amyloid species<br> 1.3. Markers of amyloid oxidative stress e.g. isoprostane and other members<br> 1.4. Markers of systemic inflammation e.g. IL-6, TNF-alpha and other inflammatory markers<br> 1.5. Other markers of APP processing e.g. BACE<br> 2. Cognitive measures:<br> 2.1. British Picture Vocabulary Scale (BPVS) at baseline<br> 2.2. Cambridge Examination for mental disorders of the elderly revised (CAMDEX-R) section on Cognitive Examination (CAMCOG) after 4 weeks maintenance lithium treatment at therapeutic dose<br>