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Memantine and Down's Syndrome

NCT00240760 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2006-02-20

No results posted yet for this study

Summary

This is a study to assess whether memantine is effective and safe in preventing age related cognitive deterioration and dementia in people with Down's syndrome (DS) age 40 and over. The study will last for a year and it will include 180 people with Down's syndrome with and without dementia. Participants will be assessed on memory skills, attention and problem solving abilities. Quality of life and abilities for everyday living skills will also be regularly checked.

Primary Aims

Clinical:

* To determine the clinical efficacy of memantine versus placebo in preventing cognitive decline in people with DS.
* To compare the safety and tolerability of memantine versus placebo in people with Down's syndrome (DS).

Biochemical and pathological:

* To examine the ability of memantine to alter markers of disease progression in DS patients.

Secondary Aims

Clinical:

* To determine whether memantine has, as compared with placebo, a significant positive impact on:

* level of independent functioning as measured by the carer-rated adaptive behavioural scale, (ABS) in adults with DS;
* quality of life in adults with DS.

Biochemical and pathological:

* To investigate putative markers of memantine's mechanism of action in peripheral samples from living patients with DS.

Conditions

  • Down's Syndrome
  • Dementia
  • Learning Disabilities

Interventions

DRUG

Memantine Hydrochloride

Sponsors & Collaborators

Principal Investigators

  • Verinder Prasher, PhD · King's College London

  • Clive G Ballard, Professor · King's College London

  • Paul Francis, PhD · King's College London

  • Ed Juszczak, PhD · University of Oxford

  • Jill Mollis, PhD · University of Oxford

  • Maria Luisa Margallo-Lana, PhD · Northgate and Prudhoe NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00240760 on ClinicalTrials.gov