Memantine for Agitation in Dementia

DEMENTIA Clinical Trial

— MAGD  

Official title:

Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371059
• Other study ID #: 2005-005087-93
• Secondary ID: ISRCTN 24953404
• Status: Completed
• Phase: Phase 4
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2022
• Source: East Kent Hospitals University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We plan to evaluate the use of memantine in Alzheimer's disease to control agitation in the acute situation i.e under 12 weeks

Description:

Agitation is a cause of morbidity and mortality in Alzheimer's due to distress and use of medication with side effects. Memantine has beed shown to be associated with less agitation and a recent study by forrest pharmaceuticals failed to recruit. We will perform a 12 week rct in 164 patients to test this hypothesis in a locality with no competing studies and in a clinical setting where the drug is not often used. We will compare with placebo and also use a rescue protocol derived from international best practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.

2. Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4.

3. Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19).

4. Clinically significant agitation that requires treatment.

5. Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45.

6. Age >/= 55.

Exclusion Criteria:

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, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks 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, history of convulsions or seizure, or receiving any anti-epileptic treatment.

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 medical illness.

11. Any disability that may interfere with the patient completing the study procedure.

12. Active malignancy.

13. Delirium, pain or any medical illness as a clear cause of agitation.

14. Any important drug interactions: Prohibited during study and in the 14 days preceding enrollment/inclusion are: Analgesic dextromethorphan, Dopaminergics- amantadine, Warfarin due to theoretical INR prolongation.

Related Conditions & MeSH terms

• DEMENTIA
• Psychomotor Agitation

Intervention

Drug:
• Memantine
Memantine 10mg BD
• Placebo
Placebo 10 mgs BD

Locations

Country	Name	City	State
United Kingdom	Oxleas Nhs Foundation Trust	Dartford	Kent
United Kingdom	Kent and Medway NHS and Social Care Partnership Trust	Folkestone	Kent

Sponsors (6)

Lead Sponsor	Collaborator
East Kent Hospitals University NHS Foundation Trust	Indiana University School of Medicine, Institute of Psychiatry, London, University College, London, University of London, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohen-Mansfield		2 weeks
Secondary	Neuropsychiatric Inventory 6+12 weeks		2 weeks
Secondary	Clinical Global Impression 6+ 12 weeks		2 weeks
Secondary	Severe Impairment Battery 6+12 weeks		2 weeks
Secondary	Quality of Life 6+12 weeks		2 weeks
Secondary	Co-meds		2 weeks
Secondary	Incidents of agitation		2 weeks
Secondary	Use of rescue protocol		2 weeks