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Health Condition(s) or Problem
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Down's Syndrome; Dementia; Learning Disabilities
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Lay Summary
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Not provided at time of registration (from ISRCTN)
Additional lay summaries...
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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Drug; Memantine Hydrochloride
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Primary aim
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Down's Attention Memory and Executive Function Scale; Part I of the Adaptive Behaviour Scale
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Secondary Aim
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The Quality of Life in Alzheimer’s Disease (Logsdon et al. 1998); Clinician’s Global Impression of Change
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Morpeth, Birmingham
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