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 older people with Down’s syndrome, with and without dementia - Memantine in people with Down's syndrome

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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.age >40 years or any age if a diagnoses 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) (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 provide input to efficacy parameters in accordance to protocol requirements,
6.not receiving treatment with Memantine 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 in agreement for participant to take part if participant is also willing

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 disorders other than dementia such as Parkinson’s disease, 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 rendered 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,
•medication for Parkinson’s disease during randomization (dopamine agonists, selegiline)
•other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, and dextromethorphan
•barbiturates and primidone
•baclofen and dantrolen
•dextrmethorphan
•antimuscarinics

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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