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	https://doi.org/10.1186/ISRCTN47562898
ClinicalTrials.gov (NCT)	NCT00240760
Clinical Trials Information System (CTIS)	2005-000381-39
Protocol serial number	KCL/DS/MEM/1
Sponsor	King's College London (UK)
Funder	Lundbeck

Submission date: 28/02/2005
Registration date: 16/05/2005
Last edited: 23/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marisa Lana
Scientific

King's College London
Wolfson Research Center for Age Related Diseases
Guy's Campus
London
SE1 1UL
United Kingdom

Phone	+44 (0)7810481267
Email	lana@onetel.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	MEADOWS study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	memantine
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).
Key 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
Completion date	31/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	180
Key inclusion criteria	People with Down's syndrome over the age of 40 and/or dementia
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/07/2005
Date of final enrolment	31/07/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College London

London
SE1 1UL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/02/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes