Memantine for Agitation in Dementia | Recruiting
Memantine for Agitation in Dementia
MAGD
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Dementia
CHRIS FOX, MBBSBscMsc
44-130-322-8836
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT00371059
Primary Trial ID Number
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
Research Details
  • 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.
Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Memantine, Drug : Placebo

Study Arm Groups : ,

Intervention Type
See Interventions above
Primary Outcome Measures
  • Cohen-Mansfield; 2 weeks
Secondary Outcome Measures
  • Neuropsychiatric Inventory 6+12 weeks; 2 weeks; Clinical Global Impression 6+ 12 weeks; 2 weeks; Severe Impairment Battery 6+12 weeks; 2 weeks; Quality of Life 6+12 weeks; 2 weeks; Co-meds; 2 weeks; Incidents of agitation; 2 weeks; Use of rescue protocol; 2 weeks
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
55 Years - N/A
Who Can Participate
Patients
Number of Participants
164
Participant Inclusion Criteria
  • 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
  • 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Pinewood House Pinewood Place
Dartford
DA2 7WG
Kent and Medway NHS and Social Care Partnership Trust
Folkestone
Kent
ct20 1jy
Trial Contact(s)
Primary Trial Contact
CHRIS FOX, MBBSBscMsc
DrChris.Fox@ekentmht.nhs.uk
44-130-322-8836
Other Trial Contacts
ADRIAN TRELOAR, MB BS Bsc
44-132-262-5700
Countries Recruiting
United Kingdom
Scientific Title
Pragmatic Randomized Control Trial of Memantine For Agitation In Dementia
EudraCT Number
Not available for this trial
Funder(s)
  • University of Oxford
  • Institute of Psychiatry, London
  • University of London
  • University College, London
  • Indiana University School of Medicine
Other Study ID Numbers
2005-005087-93
Sponsor(s)
East Kent Hospitals University NHS Foundation Trust
Key Dates

Recruitment Start Date

Sep 2007

Recruitment End Date

Jun 2009

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

30 Aug 2006

Last Updated

07 May 2008