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Efficacy and Safety of Memantine Hydrochloride, a low affinity antagonist to N-Methyl-D-Aspartate (NMDA) type receptors, in the prevention of cognitive decline and disease progression in older people with Down's syndrome, with and without dementia
ISRCTN ISRCTN47562898
DOI 10.1186/ISRCTN47562898
ClinicalTrials.gov identifier NCT00240760
EudraCT number 2005-000381-39
Public title Efficacy and Safety of Memantine Hydrochloride, a low affinity antagonist to N-Methyl-D-Aspartate (NMDA) type receptors, in the prevention of cognitive decline and disease progression in older people with Down's syndrome, with and without dementia
Scientific title
Acronym MEADOWS study
Serial number at source KCL/DS/MEM/1
Study hypothesis This is a prospective, fifty-two week, multicentre, randomised, double-blind, placebo-controlled parallel group clinical trial in people with Down's syndrome, age over 40 and people with Down's syndrome and/or dementia. The study is designed to evaluate the efficacy, safety and tolerability of memantine in this population.

Primary Aims:
1. Clinical: To determine the clinical efficacy of memantine versus placebo in preventing cognitive decline in people with Down's syndrome (DS). To compare the safety and tolerability of memantine versus placebo in people with Down's syndrome (DS).
2. Biochemical and pathological: To examine the ability of memantine to alter markers of disease progression in DS patients.

Secondary Aims:
1. Clinical: To determine whether memantine has, as compared with placebo, a significant positive impact on: the independent functioning level as measured by the carer-rated adaptive behavioural scale, (ABS) in adults with Down's syndrome suffering from dementia, quality of life in adults with Down's syndrome suffering from dementia.
2. Biochemical and pathological: To investigate putative markers of memantine's mechanism of action in peripheral samples from living patients with DS.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cognitive decline and dementia in Down's syndrome
Participants - inclusion criteria People with Down's syndrome over the age of 40 and/or dementia
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/07/2005
Anticipated end date 31/07/2006
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions Randomized, double blind, placebo controlled trial of Memantine versus placebo to assess the safety and efficacy of Memantine in preventing cognitive decline in adults with Down syndrome; effect of memantine on key progression disease markers of Alzheimer's disease in Down's syndrome.
Primary outcome measure(s) Comparing Memantine to placebo. Changes in performance from baseline on a neuropsychological battery of tests for people with DS focussing upon 3 cognitive areas: attention, memory and executive function (the DAME, battery).
Secondary outcome measure(s) Comparing Memantine to placebo:
1. Incidence of dementia (International Statistical Classification of Diseases and Related Health Problems - tenth revision [ICD-10] criteria)
2. Changes in performance from baseline on the Adaptive Behavioural
Scale (ABS)
3. Changes in performance from baseline on quality of life (QOL-AD)
4. Changes in performance from baseline on Clinical Global Impression of
Change
5. Changes in key biomarkers
Sources of funding Lundbeck
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22236802
Contact name Dr  Marisa  Lana
  Address King's College London
Wolfson Research Center for Age Related Diseases
Guy's Campus
  City/town London
  Zip/Postcode SE1 1UL
  Country United Kingdom
  Tel +44 (0)7810481267
  Fax +44 (0)1670 394825
  Email lana@onetel.com
Sponsor King's College London (UK)
  Address Prof Sir Graeme Catto
Vice Principal
The Principal's Office
JCMB 5.27
King's College London
57 Waterloo Road
  City/town London
  Zip/Postcode SE1 8WA
  Country United Kingdom
Date applied 28/02/2005
Last edited 23/02/2012
Date ISRCTN assigned 16/05/2005
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