Memantine and Down's Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by King's College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT00240760
First received: October 14, 2005
Last updated: February 17, 2006
Last verified: October 2005
  Purpose

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.

Condition Intervention
Down's Syndrome
Dementia
Learning Disabilities
Drug: Memantine Hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • Down's Attention Memory and Executive Function Scale
  • Part I of the Adaptive Behaviour Scale

Secondary Outcome Measures:
  • The Quality of Life in Alzheimer’s Disease (Logsdon et al. 1998)
  • Clinician’s Global Impression of Change

Estimated Enrollment: 180
Study Start Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria will be:

  1. Participants with learning disabilities due to Down’s syndrome (DS) confirmed by karyotype. A clinical diagnosis (provided by the participant’s general practitioner or hospital specialist) will be accepted if karyotype is not known and participant does not agree to have it tested
  2. Ages 40 years and over or any age if a diagnosis of dementia is established
  3. In participants with dementia, the diagnosis will be consistent with the 10th version of the International Classification of Diseases (ICD-10) (World Health Organization [WHO], 1992) diagnostic criteria
  4. Level of speech and comprehension of verbal commands are sufficient to understand and to answer simple requests
  5. Resident in care facility or community living with a carer who is willing to accept responsibility for supervising the treatment and will provide input to efficacy parameters in accordance with protocol requirements
  6. Not receiving treatment with memantine currently or in past 4 weeks and responsible clinician not considering treatment with memantine
  7. Participant willing to take part in study; and carer, with capacity, willing to assent to study and agrees that participant can take part if participant is also willing.

Exclusion Criteria:

Exclusion criteria will be:

  1. Participants known to have sensitivity to memantine
  2. Severe, unstable or uncontrolled medical or psychiatric conditions apparent from history, physical examination or investigations
  3. A current diagnosis of primary neurodegenerative disorder other than dementia such as Huntington’s disease, etc.
  4. Uncontrolled epilepsy
  5. Presence of challenging behaviour likely to preclude the participation during testing
  6. Presence of severe motor or sensory impairment (severe deafness or blindness) that renders the participant as untestable with the battery of tests used in the study
  7. Current evidence of delirium
  8. Severe renal impairment
  9. Low probability of treatment compliance
  10. Previous evidence of lack of efficacy or tolerability to memantine
  11. Taking any of the following substances:

    • an investigational drug during the 4 weeks prior to randomization
    • a drug known to cause major organ system toxicity during the 4 weeks prior to randomization
    • started any new psychotropic during the 4 weeks prior to randomization; participants who had been on a stable dose of psychotropic during the 4 weeks prior to randomization are still eligible.
    • memantine during the 6 weeks prior to randomization
    • other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, and dextromethorphan
    • barbiturates and primidone
    • baclofen and dantrolen
    • dextromethorphan
    • antimuscarinics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240760

Contacts
Contact: Maria Luisa Margallo-Lana, PhD lana@onetel.com
Contact: Verinder Prasher, PhD vprasher@compuserver.com

Locations
United Kingdom
Northgate Hospital Recruiting
Morpeth, Northumberland, United Kingdom, NE61 3BP
Contact: Maria Luisa Margallo-Lana, PhD    0044 (0) 1670394000 ext 4079    lana@onetel.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         
Sponsors and Collaborators
King's College London
Investigators
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 Oxford University
Principal Investigator: Jill Mollis, PhD Oxford University
Principal Investigator: Maria Luisa Margallo-Lana, PhD Northgate and Prudhoe NHS Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00240760     History of Changes
Other Study ID Numbers: KCL/DS/MEM/1, EUDRACT- 2005 000381 39, ISRCTN47562898
Study First Received: October 14, 2005
Last Updated: February 17, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by King's College London:
Memantine
Down syndrome
Dementia
learning Disability
Treatment of Dementia

Additional relevant MeSH terms:
Learning Disorders
Syndrome
Dementia
Down Syndrome
Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Communication Disorders
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014