This is a trial to look at the treatment of Downs Syndrome patients with Lithium Carbonate versus placebo

Genetically determined brain abnormalities in Down’s Syndrome.- towards a treatment: A randomised, single-blind, placebo-controlled trial of lithium carbonate in Down’s Syndrome (DownsLit). - Downs Syndrome Lithium Trial (DownsLit)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008342-20-GB

Enrollment

Registered

2009-07-09

Start date

2009-02-23

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down's Syndrome MedDRA version: 14.0 Level: LLT Classification code 10013616 Term: Down's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Camcolit 250 Product Name: CAMCOLIT 250mg Lithium Carbonate Product Code: NO5AN01 Pharmaceutical Form: Tablet CAS Number: 554132 Other descriptive name: Lithium Carbonate Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Individuals with Down Syndrome • Over the age of 18 years • Able to provide informed consent or have a legal representative to consent on their behalf if they lack capacity • Able to communicate with the investigator and to comply with requirements of the study • Has carer support Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: • Individuals with contraindications to lithium treatment • Individuals with contraindications to undergoing a magnetic resonance scan • Non-compliance with taking of the tablets between baseline and the 4-week assessment • Treatment with lithium within the last 6 months • Evidence of dementia • Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Our primary objective is to determine if brain myo-inositol concentration is significantly reduced in non-demented DS individuals by brief 4 week treatment with lithium carbonate at normal therapeutic doses with full monitoring of potential side effects in all participants. ;Secondary Objective: Our secondary objectives are to: • Investigate the association of clinical and biomarker measures to any changes in brain myo-inositol concentrations • Determine whether lithium has a differential impact on different genotypes that confer additional risk of AD in DS e.g. tau haplotypes, ApoE4 and other polymorphisms that affect amyloid processing e.g. intron 7 repeat of APP • Also look at broader range of biomarkers to determine the impact of lithium on the brains of individuals with DS, including markers of amyloid oxidative stress and systemic inflammation ;Primary end point(s): Our primary objective is to determine if brain myo-inositol concentration is significantly reduced in non-demented DS individuals by brief 4 week treatment with lithium carbonate at normal therapeutic doses with full monitoring of potential side effects in all participants;Timepoint(s) of evaluation of this end point: 8 weeks	—

Measure

Time frame

Main Objective: Our primary objective is to determine if brain myo-inositol concentration is significantly reduced in non-demented DS individuals by brief 4 week treatment with lithium carbonate at normal therapeutic doses with full monitoring of potential side effects in all participants. ;Secondary Objective: Our secondary objectives are to: • Investigate the association of clinical and biomarker measures to any changes in brain myo-inositol concentrations • Determine whether lithium has a differential impact on different genotypes that confer additional risk of AD in DS e.g. tau haplotypes, ApoE4 and other polymorphisms that affect amyloid processing e.g. intron 7 repeat of APP • Also look at broader range of biomarkers to determine the impact of lithium on the brains of individuals with DS, including markers of amyloid oxidative stress and systemic inflammation ;Primary end point(s): Our primary objective is to determine if brain myo-inositol concentration is significantly reduced in non-demented DS individuals by brief 4 week treatment with lithium carbonate at normal therapeutic doses with full monitoring of potential side effects in all participants;Timepoint(s) of evaluation of this end point: 8 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Our secondary objectives are to: • Investigate the association of clinical and biomarker measures to any changes in brain myo-inositol concentrations • Determine whether lithium has a differential impact on different genotypes that confer additional risk of AD in DS e.g. tau haplotypes, ApoE4 and other polymorphisms that affect amyloid processing e.g. intron 7 repeat of APP • Also look at broader range of biomarkers to determine the impact of lithium on the brains of individuals with DS, including markers of amyloid oxidative stress and systemic inflammation ;Timepoint(s) of evaluation of this end point: 8 weeks	—

Measure

Time frame

Secondary end point(s): Our secondary objectives are to: • Investigate the association of clinical and biomarker measures to any changes in brain myo-inositol concentrations • Determine whether lithium has a differential impact on different genotypes that confer additional risk of AD in DS e.g. tau haplotypes, ApoE4 and other polymorphisms that affect amyloid processing e.g. intron 7 repeat of APP • Also look at broader range of biomarkers to determine the impact of lithium on the brains of individuals with DS, including markers of amyloid oxidative stress and systemic inflammation ;Timepoint(s) of evaluation of this end point: 8 weeks

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Countries

United Kingdom

Contacts

Public ContactProfessor Declan Murphy

Kings College London

declan.murphy@kcl.ac.uk00442078480984

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026