Memantine in DEMENTIA - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

DEMENTIA

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- Kent
  - Dartford, Kent, United Kingdom, DA2 7WG
    - Oxleas NHS Foundation Trust
  - Folkestone, Kent, United Kingdom, ct20 1jy
    - Kent and Medway NHS and Social Care Partnership Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Residential/Inpatients at recruitment to the study with a history of at least 2 weeks behavioural disturbance.
Alzheimer's Disease only as per McKhann Criteria + Hachinski Score<=4.
Moderately severe to severe Alzheimer's Disease (baseline MMSE </=19).
Clinically significant agitation that requires treatment.
Severity of agitation defined by Cohen Mansfield agitation inventory (CMAI) > /=45.
Age >/= 55.

Exclusion Criteria:

Memantine usage in the 4 weeks prior to the start of the study.
On Cholinesterase inhibitor for less than 3 months and not on a stable dose.
Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study.
Antiparkinsonian medication.
Hypersensitivity to memantine or any of the excipients in the formulation.
Severe renal impairment.
Epilepsy, history of convulsions or seizure, or receiving any anti-epileptic treatment.
Concomitant usage of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan.
Recent myocardial infarction, uncompensated congestive heart failure and uncontrolled hypertension.
Severe, unstable or poorly controlled medical illness.
Any disability that may interfere with the patient completing the study procedure.
Active malignancy.
Delirium, pain or any medical illness as a clear cause of agitation.
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: QUADRUPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cohen-Mansfield Time Frame: 2 weeks	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Neuropsychiatric Inventory 6+12 weeks Time Frame: 2 weeks	2 weeks
Clinical Global Impression 6+ 12 weeks Time Frame: 2 weeks	2 weeks
Severe Impairment Battery 6+12 weeks Time Frame: 2 weeks	2 weeks
Quality of Life 6+12 weeks Time Frame: 2 weeks	2 weeks
Co-meds Time Frame: 2 weeks	2 weeks
Incidents of agitation Time Frame: 2 weeks	2 weeks
Use of rescue protocol Time Frame: 2 weeks	2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Kent Hospitals University NHS Foundation Trust

Collaborators

University College, London

University of Oxford

University of London

Indiana University School of Medicine

Institute of Psychiatry, London

Investigators

Principal Investigator: CHRIS FOX, MBBSBscMSC, Kent and Medway NHS and Social Care Partnership Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Fox C, Crugel M, Maidment I, Auestad BH, Coulton S, Treloar A, Ballard C, Boustani M, Katona C, Livingston G. Efficacy of memantine for agitation in Alzheimer's dementia: a randomised double-blind placebo controlled trial. PLoS One. 2012;7(5):e35185. doi: 10.1371/journal.pone.0035185. Epub 2012 May 2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria