Genetically determined brain abnormalities in Down's syndrome - towards a treatment: Down's syndrome Lithium Trial
ISRCTN | ISRCTN03784241 |
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DOI | https://doi.org/10.1186/ISRCTN03784241 |
EudraCT/CTIS number | 2008-008342-20 |
Secondary identifying numbers | Sponsor ID: RAA08-015; EudraCT number: 2008-008342-20 |
- Submission date
- 28/05/2009
- Registration date
- 19/08/2009
- Last edited
- 20/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Professor of Psychiatry and Brain Maturation
Institute of Psychiatry
Section of Brain Maturation, PO50
De Crespigny Park
London
SE5 8AF
United Kingdom
Study information
Study design | Single-centre randomised single-blind placebo-controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study acronym | DOWNSLIT |
Study objectives | 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(s) | South East Research Ethics Committee, 23/02/2009, ref: 09/H1102/3 |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Lithium carbonate (Camcolit®) |
Primary outcome measure | 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 study start date | 01/06/2009 |
Completion date | 31/12/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 34 |
Total final enrolment | 19 |
Key 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 |
Key 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 |
Date of first enrolment | 01/06/2009 |
Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE5 8AF
United Kingdom
Sponsor information
University/education
c/o Professor Peter McGuffin
Dean and Head of School
Institute of Psychiatry
PO Box 001
De Crespigny Park
London
SE5 8AF
England
United Kingdom
Website | http://www.iop.kcl.ac.uk/ |
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https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Baily Thomas Charitable Fund
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Basic results | 20/05/2019 | No | No | ||
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/05/2019: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.