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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47562898

Enrollment

180

Registered

2005-05-16

Start date

2005-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive decline and dementia in Down's syndrome Nervous System Diseases

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.

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026