Memantine and Down's Syndrome

NCT00240760 | Unknown

• 3 other identifiers: KCL/DS/MEM/1EUDRACT- 2005 000381 39ISRCTN47562898
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Memantine; Down syndrome; Dementia; learning Disability; Treatment of Dementia

Outcome Measures

Primary Outcomes (2)

• Down's Attention Memory and Executive Function Scale

• Part I of the Adaptive Behaviour Scale

Secondary Outcomes (2)

• The Quality of Life in Alzheimer's Disease (Logsdon et al. 1998)

• Clinician's Global Impression of Change

Interventions

Memantine Hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ages 40 years and over or any age if a diagnosis of dementia is established
• 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
• Level of speech and comprehension of verbal commands are sufficient to understand and to answer simple requests
• 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
• Not receiving treatment with memantine currently or in past 4 weeks and responsible clinician not considering treatment with memantine
• 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.

You may not qualify if:

• Participants known to have sensitivity to memantine
• Severe, unstable or uncontrolled medical or psychiatric conditions apparent from history, physical examination or investigations
• A current diagnosis of primary neurodegenerative disorder other than dementia such as Huntington's disease, etc.
• Uncontrolled epilepsy
• Presence of challenging behaviour likely to preclude the participation during testing
• 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
• Current evidence of delirium
• Severe renal impairment
• Low probability of treatment compliance
• Previous evidence of lack of efficacy or tolerability to memantine
• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (2)

Monyhull Hall Road

Birmingham, Birmingham, B30 3QQ, United Kingdom

RECRUITING

Northgate Hospital

Morpeth, Northumberland, NE61 3BP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Down Syndrome; Dementia; Learning Disabilities

Interventions

Memantine

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Communication Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Verinder Prasher, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Clive G Ballard, Professor

  King's College London

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Luisa Margallo-Lana, PhD

CONTACT

lana@onetel.com

Verinder Prasher, PhD

CONTACT

vprasher@compuserver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: October 1, 2005
• Last Updated: February 20, 2006

Record last verified: 2005-10

Locations

GB (2)