NCT00371059

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

August 30, 2006

Last Update Submit

March 28, 2022

Conditions

DEMENTIA

Keywords

AgitationDementiaAlzheimer's

Outcome Measures

Primary Outcomes (1)

  • Cohen-Mansfield

    2 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

MemantineDRUG

Memantine 10mg BD

PlaceboDRUG

Placebo 10 mgs BD

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oxleas Nhs Foundation Trust

Dartford, KENT, DA2 7WG, United Kingdom

Location

Kent and Medway NHS and Social Care Partnership Trust

Folkestone, Kent, ct20 1jy, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 22567095DERIVED

MeSH Terms

Conditions

DementiaPsychomotor Agitation

Interventions

Memantine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • CHRIS FOX, MBBSBscMSC

    KENT AND MEDWAY NHS AND SOCIAL CARE PARTNERSHIP TRUST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2006

First Posted

September 1, 2006

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations

GB(2)