Memantine and Down's Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00240760|
Recruitment Status : Unknown
Verified October 2005 by King's College London.
Recruitment status was: Recruiting
First Posted : October 18, 2005
Last Update Posted : February 20, 2006
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.
- 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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Down's Syndrome Dementia Learning Disabilities||Drug: Memantine Hydrochloride||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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 Down's Syndrome|
|Study Start Date :||October 2005|
- Down's Attention Memory and Executive Function Scale
- Part I of the Adaptive Behaviour Scale
- The Quality of Life in Alzheimer's Disease (Logsdon et al. 1998)
- Clinician's Global Impression of Change
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240760
|Contact: Maria Luisa Margallo-Lana, PhDemail@example.com|
|Contact: Verinder Prasher, PhDfirstname.lastname@example.org|
|Morpeth, Northumberland, United Kingdom, NE61 3BP|
|Contact: Maria Luisa Margallo-Lana, PhD 0044 (0) 1670394000 ext 4079 email@example.com|
|Principal Investigator: Maria Luisa Margallo-Lana, PhD|
|Monyhull Hall Road||Recruiting|
|Birmingham, United Kingdom, B30 3QQ|
|Contact: Verinder Prasher, PhD 0044 (0) 121 255 8013 vprasher@compuserver|
|Principal Investigator: Verinder Prasher, PhD|
|Principal Investigator:||Verinder Prasher, PhD||King's College London|
|Study Director:||Clive G Ballard, Professor||King's College London|
|Principal Investigator:||Paul Francis, PhD||King's College London|
|Principal Investigator:||Ed Juszczak, PhD||University of Oxford|
|Principal Investigator:||Jill Mollis, PhD||University of Oxford|
|Principal Investigator:||Maria Luisa Margallo-Lana, PhD||Northgate and Prudhoe NHS Trust|