Condition category
Not Applicable
Date applied
28/05/2009
Date assigned
19/08/2009
Last edited
30/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Declan Murphy

ORCID ID

Contact details

Professor of Psychiatry and Brain Maturation
Institute of Psychiatry
Section of Brain Maturation
PO50
De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

2008-008342-20

ClinicalTrials.gov number

Protocol/serial number

Sponsor ID: RAA08-015; EudraCT number: 2008-008342-20

Study information

Scientific title

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

Acronym

DOWNSLIT

Study hypothesis

That brain myo-inositol levels in non-demented Down's syndrome individuals can be reduced by a 4-week trial of lithium carbonate at therapeutic doses.

Ethics approval

South East Research Ethics Committee, 23/02/2009, ref: 09/H1102/3

Study design

Single-centre randomised single-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Down's syndrome

Intervention

Lithium carbonate (Camcolit®), 250 mg oral tablets versus placebo.

Titration phase: dose adjusted to achieve therapeutic plasma level of 0.4-1.0 mmol/l
Maintenance phase: twice daily dosing for 4 weeks on therapeutic lithium carbonate dose
Titration phase: dose adjusted to achieve therapeutic plasma level of 0.4-1.0mmol/L
Maintenance phase: twice daily dosing for 4 weeks on therapeutic lithium carbonate dose

Total duration of treatment is around 8 weeks; follow-up will be as appropriate if patients have any side-efects on lithium, otherwise patient involvement ends when they come off the medication. Likewise for placebo group.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lithium carbonate (Camcolit®)

Primary outcome measures

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

1. Blood biomarkers which have been implicated in the development of Alzheimer's disease:
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
1.2. Abeta1-40, Abeta1-42 base fragments and other amyloid species
1.3. Markers of amyloid oxidative stress e.g. isoprostane and other members
1.4. Markers of systemic inflammation e.g. IL-6, TNF-alpha and other inflammatory markers
1.5. Other markers of APP processing e.g. BACE
2. Cognitive measures:
2.1. British Picture Vocabulary Scale (BPVS) at baseline
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

Overall trial start date

01/06/2009

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant 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

Recruitment start date

01/06/2009

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Psychiatry and Brain Maturation
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Professor Peter McGuffin
Dean and Head of School
Institute of Psychiatry
PO Box 001
De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

Baily Thomas Charitable Fund (UK) (ref: 2215/1)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes