EUCTR2007-004897-26-GB
Active, not recruiting
Phase 1
Memantine for the Long Term Management of Neuropsychiatric Symptoms in Alzheimer's disease - MAIN-AD - MAIN-AD
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- King's College London
- Enrollment
- 300
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Living: in a nursing or social care facilities.
- •Fulfil the NINCDS/ADRDA criteria for possible or probable Alzheimer's disease (AD).
- •Taking at least 0\.5mg daily of haloperidol, 0\.5mg daily of risperidone, 5mg daily of olanzapine or 25mg daily of quetiapine or another neuroleptic which in the opinion of the responsible clinician could be safely converted to one of these neuroleptics, for a minimum of 3 months prior to entry into the study.
- •If taking a cholinesterase inhibitor, prescribed for at least 6 months before the date of assessment, with a stable dose for at least 3 months.
- •Not taking anticonvulsants other than carbamazepine or sodium valproate. The use of either of these 2 agents is permissible if the dose has been stable for at least 4 weeks.
- •If taking any other psychotropic drugs (eg antidepressants, benzodiazepines, chlormethiazole), the dose has been stable for at least 4 weeks prior to randomization.
- •Not receiving treatment with memantine or have taken memantine in the past 6 weeks, and responsible clinician not considering treatment with memantine.
- •MMSE score \=3 and \=15\.
- •Not taking any medications that are contra\-indicated or not recommended in combination with memantine, as defined in the British National Formulary, including ketamine, dextromethorphan, amantidine.
- •Written informed consent provided by the participant’s next of kin or a legal representative.
Exclusion Criteria
- •Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition (including marked extra\-pyramidal disorder), which would make participation in the trial distressing or likely to increase suffering.
- •Patients with a systolic blood pressure whilst sitting greater than 180 mm/Hg or less than 90 mm/Hg, or a diastolic blood pressure whilst sitting greater than 100 mm/Hg or less than 50 mm/Hg at the screening visits or baseline.
- •Patients with a recent history (within 3 months of screening) or currently untreated B12 or folate deficiency.
- •Patients with a recent history (within 3 months) or untreated clinically significant hypothyroidism or hyperthyroidism (patients with thyroid disease may be included provided they are euthyroid and stable).
- •Severe aggression (\=8\) on item 3 of the NPI subscale, with aggression as the predominant symptom.
- •Patients with psychotic DSM IV TR Axis 1 disorder other than in the context of Alzheimer’s disease, including schizophrenia, schizoaffective disorder and bipolar disorder.
- •Participants known to have sensitivity to memantine, amantadine, rimantidine or lactose
- •A current diagnosis of primary neurodegenerative disorders other than Alzheimer’s disease such as, Huntington’s disease, Parkinson’s disease, etc.
- •Uncontrolled epilepsy.
- •Current evidence of delirium.
Investigators
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