A randomized double blind placebo controlled trial of Memantine in the treatment of Agitation in Alzheimers Dementia - MAGD trail (Memantine for Agitation in Dementia)
- Conditions
- Alzheimers dementia
- Registration Number
- EUCTR2005-005087-93-GB
- Lead Sponsor
- East Kent Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 164
1. Residential/Inpatients at recruitment with a history of at least 2 weeks behavioural disturbance
2. Alzheimer’s Disease only as per NINCDS-ADRDA Criteria (McKhann et al 1984) + Haschinski Score<=4.
3. Moderately severe to severe Alzheimer’s Disease (as determined by baseline MMSE < 19).
4. Clinically significant agitation that requires pharmacological or non pharmacological treatment.
5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) = 45 (Cohen Mansfield 1995).
6. Age > 45.
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
1.Memantine usage in the 4 weeks prior to the start of the study.
2. On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
3. Anti-psychotic, benzodiazepine or hypnotic dosage alteration in the week prior to the start of the study.
4. Antiparkinsonian medication
5. Hypersensitivity to memantine or any of the excipients in the formulation.
6. Severe renal impairment.
7. Epilepsy or history of convulsions or receiving antiepileptic medication.
8. Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
9. Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
10. Severe, unstable or poorly controlled acute or chronic medical illness.
11. Any disability that may interfere with the patient completing the study procedure.
12. Active malignancy.
13. Any medical illness as a clear cause of agitation, including Delirium + pain.
14. Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorpan, Dopaminergics- amantadine. Warfarin due to INR prolongation.
During the study patients will be allowed to continue taking stable doses of concomitant medicines including antidepressants, antihypertensives, anti-inflammatory drugs, atypical anti-psychotics, anticoagulants, laxatives, diuretics, hypnotics and benzodiazepines (Tariot et al, 2004). Concomitant administration of anti-parkinsonian medication will be permitted but stable dose and no patients on amantadine this is to avoid difficulties with PD stability as Memantine can have benefit in PD. Cholinesterase inhibitors will not be permitted unless patients have been stable on that medication for at least 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the efficacy of memantine in the treatment of Agitation in Alzheimer's dementia;<br> Secondary Objective: 1.To investigate the effect of Memantine on the subtypes of agitation such as verbal and physical aggression.<br> 2.To investigate the effect of Memantine on other secondary outcome measures, namely activities of daily living, other BPSD symptoms, the need for rescue pharmacological intervention such hypnotics and antipsychotics, cognitive functioning.<br> 3.To investigate what baseline factors predict clinical response.<br> 4. To investigate whether there are any adverse effects of Memantine treatment in the study population.<br> ;Primary end point(s): Change in CMAI at 6 weeks at 10mg twice daily dose – primary hypothesis 6 point difference in change score in favour of memantine. Intermediate assessment points at 2, 4, and 6 weeks.
- Secondary Outcome Measures
Name Time Method