EUCTR2005-000381-39-GB进行中（未招募）1 期
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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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