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 |
| EudraCT/CTIS number | 2005-000381-39 |
| ClinicalTrials.gov number | NCT00240760 |
| Secondary identifying numbers | KCL/DS/MEM/1 |
- 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
Not provided at time of registration
Contact information
Dr Marisa Lana
Scientific
Scientific
King's College London
Wolfson Research Center for Age Related Diseases
Guy's Campus
London
SE1 1UL
United Kingdom
| Phone | +44 (0)7810481267 |
|---|---|
| lana@onetel.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study 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(s) | Not provided at time of registration |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | memantine |
| Primary outcome measure | 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 study start date | 01/07/2005 |
| Overall study end date | 31/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 180 |
| Participant inclusion criteria | People with Down's syndrome over the age of 40 and/or dementia |
| 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
- England
- United Kingdom
Study participating centre
King's College London
London
SE1 1UL
United Kingdom
SE1 1UL
United Kingdom
Sponsor information
King's College London (UK)
Not defined
Not defined
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
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Industry
Lundbeck
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 11/02/2012 | Yes | No |
