Condition category
Nervous System Diseases
Date applied
08/01/2008
Date assigned
14/02/2008
Last edited
20/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Clive Ballard

ORCID ID

Contact details

Wolfson Centre for Age-Related Diseases
Wolfson Wing
Hodgkin Building
King's College London
Guy's Campus
London
SE1 1UL
United Kingdom
+44 20 7848 8054
clive.ballard@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol Version 4, 8/7/2007

Study information

Scientific title

Memantine for the Long Term Management of Neuropsychiatric Symptoms in Alzheimer's disease (MAIN-AD)

Acronym

MAIN-AD

Study hypothesis

The principal research objective is to investigate the efficacy and safety of memantine when compared to neuroleptics in the long-term management of neuropsychiatric symptoms in people with Alzheimer's disease.

Ethics approval

Multi-centre Research Ethics Committee for Wales, 28/03/2008, ref: 08/MRE09/5

Study design

Multi-centre double-blind placebo-controlled double-dummy parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alzheimer's disease

Intervention

Intervention group: Memantine + placebo neuroleptic for 24 weeks
Control group: Neuroleptic + placebo memantine for 24 weeks

The choice of neuroleptic and dose will be made by the responsible clinician. The neuroleptics allowed are haloperidol, risperidone, olanzapine and quetiapine.

Intervention type

Drug

Phase

Not Applicable

Drug names

Memantine

Primary outcome measures

The following will be assessed at baseline, week 6, week 12 and week 24:
1. Bristol Activities of Daily Living scale. Please note that only the week 24 outcome will be considered as the primary outcome.
2. Cohen-Mansfield agitation inventory.

Secondary outcome measures

The following will be assessed at baseline, week 6, week 12 and week 24:
1. Neuropsychiatric inventory
2. Severe impairment battery
3. Mini-mental state examination
4. Letter fluency (FAS) test
5. Functional assessment staging
6. Modified D test
7. Clinical global impression of change
8. Modified unified Parkinson's disease rating scale
9. Abnormal involuntary movement scale

Overall trial start date

01/04/2008

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Living in a nursing or social care facilities
2. Fulfill the National Institute of Neurological and Communication Disorders and Stroke/ Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for possible or probable Alzheimer's Disease (AD)
3. Taking at least 0.5 mg daily of haloperidol, 0.5 mg daily of risperidone, 5 mg daily of olanzapine or 25 mg daily of quetiapine or another neuroleptic which in the opinion of the responsible clinician could be safely converted to one of these neuroleptics, for a minimum of 3 months prior to entry into the study
4. If taking a cholinesterase inhibitor, prescribed for at least 6 months before the date of assessment, with a stable dose for at least 3 months
5. Not taking anticonvulsants other than carbamazepine or sodium valproate. The use of either of these 2 agents is permissible if the dose has been stable for at least 4 weeks
6. If taking any other psychotropic drugs (e.g., antidepressants, benzodiazepines, chlormethiazole), the dose has been stable for at least 4 weeks prior to randomization
7. Have not received memantine in the last 6 weeks
8. Taking any medications that are contra-indicated or not recommended in combination with memantine, as defined in the British National Formulary, including ketamine, dextromethorphan and amantidine
9. Written informed consent provided by the participant (if they have capacity) and/or their next of kin or a legal representative

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Current evidence of delirium
2. Moderately severe renal impairment, as measured by or equivalent to an estimated creatinine clearance of <50 mL/min/1.73 m2
3. Severe hepatic impairment
4. Unable to swallow tablets or capsules
5. Low probability of treatment compliance
6. Currently taking memantine
7. Previous evidence of lack of efficacy or tolerability to memantine
8. Taking any of the following substances:
8.1. An investigational drug during the 4 weeks prior to randomization
8.2. A drug known to cause major organ system toxicity during the 4 weeks prior to randomization.
8.3. Started any new psychotropic medication during the 4 weeks prior to randomization. Participants who have been on a stable dose of psychotropic during the 4 weeks prior to randomization are still eligible
8.4. Memantine during the 6 weeks prior to randomization
8.5. Other N-methyl-D-aspartate (NMDA) antagonists: amantadine, ketamine, and dextromethorphan.
8.6. Barbiturates and primidone
8.7. Baclofen and dantrolen
8.8. Dextromethorphan
8.9. Antimuscarinics
8.10. Anticonvulsants other than sodium valproate or carbamazepine. These 2 agents are permissible if doses have been stable for at least 4 weeks

Recruitment start date

01/04/2008

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE1 1UL
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Hodkin Building
Guy's Campus
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

http://kcl.ac.uk

Funders

Funder type

Industry

Funder name

Lundbeck Pharmaceutical (Contact: Dr Ya'acov Leigh, Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG, UK. E-mail: YALE@lundbeck.com)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25523285

Publication citations

Additional files

Editorial Notes

20/06/2016: Publication reference added.