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

Completed

• Conditions: Cognitive decline and dementia in Down's syndrome; Nervous System Diseases

• Registration Number: ISRCTN47562898
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Comparing Memantine to placebo:<br>1. Incidence of dementia (International Statistical Classification of Diseases and Related Health Problems - tenth revision [ICD-10] criteria)<br>2. Changes in performance from baseline on the Adaptive Behavioural <br>Scale (ABS)<br>3. Changes in performance from baseline on quality of life (QOL-AD)<br>4. Changes in performance from baseline on Clinical Global Impression of <br>Change<br>5. Changes in key biomarkers