Condition category
Nervous System Diseases
Date applied
28/02/2005
Date assigned
16/05/2005
Last edited
23/02/2012
Prospective/Retrospective
Prospectively 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

Dr Marisa Lana

ORCID ID

Contact details

King's College London
Wolfson Research Center for Age Related Diseases
Guy's Campus
London
SE1 1UL
United Kingdom
+44 (0)7810481267
lana@onetel.com

Additional identifiers

EudraCT number

2005-000381-39

ClinicalTrials.gov number

NCT00240760

Protocol/serial number

KCL/DS/MEM/1

Study information

Scientific title

Acronym

MEADOWS study

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

Cognitive decline and dementia in Down's syndrome

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

memantine

Primary outcome measures

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 measures

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

Overall trial start date

01/07/2005

Overall trial end date

31/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

People with Down's syndrome over the age of 40 and/or dementia

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

180

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2005

Recruitment end date

31/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 1UL
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Prof Sir Graeme Catto
Vice Principal
The Principal's Office
JCMB 5.27
King's College London
57 Waterloo Road
London
SE1 8WA
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Lundbeck

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22236802

Publication citations

  1. Results

    Hanney M, Prasher V, Williams N, Jones EL, Aarsland D, Corbett A, Lawrence D, Yu LM, Tyrer S, Francis PT, Johnson T, Bullock R, Ballard C, , Memantine for dementia in adults older than 40 years with Down's syndrome (MEADOWS): a randomised, double-blind, placebo-controlled trial., Lancet, 2012, 379, 9815, 528-536, doi: 10.1016/S0140-6736(11)61676-0.

Additional files

Editorial Notes