Clinical Trial Details
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NCT00240760 : Memantine and Down's Syndrome
AgesMin: 18 Years Max: N/A
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

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

- 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

- barbiturates and primidone

- baclofen and dantrolen

- dextromethorphan

- antimuscarinics
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