Condition category
Nervous System Diseases
Date applied
08/09/2005
Date assigned
14/09/2005
Last edited
05/08/2009
Prospective/Retrospective
Retrospectively 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

Dr Iracema Leroi

ORCID ID

Contact details

Park House
North Manchester General Hospital
Delaunay's Road
Crumpsall
Manchester
M8 5RB
United Kingdom
+44 (0)1617202497
ILeroi2002@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3

Study information

Scientific title

Acronym

Study hypothesis

To investigate the safety and efficacy of memantine used for treatment of cognitive and functional impairment in Parkinson's disease.

Ethics approval

(Added 05/08/09) North Manchester Regional Ethics Committee (NMREC) gave approval on the 20th November 2003 (ref: 03/NM/359)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Parkinson's disease dementia

Intervention

Memantine, a new glutamatergic modulator used for treatment of cognitive and functional impairment in Alzheimer disease versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Memantine

Primary outcome measures

Neuropsychological function including measures of:
1. Global cognitive impairment with emphasis on subcortical functions as assessed by the Dementia Rating Scale (DRS)(Mattis, 1988). This scale examines five areas including: attention, initiation and perseveration, construction, conceptual ability, and memory (verbal and visual).
2. Psychomotor speed and tracking as assessed by Trail Making Test, Part A and B (TMT) (Reitan, 1958).
3. Executive function as assessed by verbal fluency (Monsch et al., 1994).

Secondary outcome measures

1. Parkinsonian motor symptoms as measured by:
1.1. The Unified Parkinson’s Disease Rating Scale, motor subscore (items 18-31)(UPDRS-motor)(Fahn et al., 1987) for assessment of baseline and change in motor symptoms. This will administered during the “on” phase or no sooner than 30minutes after administration of anti-Parkinsonian medications.
1.2. The Hoehn-Yahr Scale (HYS)(the same as UPDRS, Part V(Hoehn and Yahr, 1967) for assessment of stage of motor severity in PD (range “0” for no signs of disease to “5” wheelchair bound or bedridden).
2. Psychiatric symptoms as measured by:
2.1. Neuropsychiatric Inventory (NPI)(Cummings et al., 1994).
2.2. Cornell Depression Rating Scale (CDRS)(Alexopolous, 1988).
2.3. Hamilton Rating Scale for Depression (Hamilton 1960).
3. Functional ability as measures by the Parkinson’s Disease Questionnaire (PDQ-39) (Jenkinson et al., 1998).
4. Global measure of change as assessed by the Clinician’s Interview Based Impression of Change (CIBIC+).

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients, minimum age of 50.
2. Have a clinical diagnosis of idiopathic Parkinson’s disease (PD) according to the UK Parkinson’s Disease Society Brain Bank clinical diagnostic criteria (Daniel and Lees, 1993), in the mild to moderate stage as defined by Hoehn and Yahr stage < V (Hoehn and Yahr, 1967).
3. Have a clinical diagnosis of PDD, according to DSM-IV criteria (Code 294.1), with onset of symptoms of dementia at least 1 year after the first onset of PD motor symptoms.
4. Have dementia within the range of MMSE 10-26.
5. Treatment of the motor aspects of the disease stable for at least one month prior to enrolling in the study.
6. Presence of a reliable caregiver or spouse to act as informant and monitor the study drug.
7. Stable medical history and general health.
8. Able to consent to the study, be cooperative, and able to ingest oral medication. Informed consent will be written, however, if the patient is incapable of giving written consent, their legally authorised representative must be able to provide this).

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patients known to have a sensitivity to NMDA receptor antagonists or who are currently on amantadine, ranitidine or cimetidine.
2. Presence of brain disease other than PD (such as vascular dementia, stroke) or history of neurosurgery.
3. Presence of severe medical disorders.
4. A disability that may prevent the patient from completing all study requirements (eg blindness, deafness).
5. Female patients of child-bearing potential.
6. Taken any cognitive enhancing agent, such as a cholinesterase inhibitor, during the four weeks prior to randomization.

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Park House
Manchester
M8 5RB
United Kingdom

Sponsor information

Organisation

Manchester Mental Health and Social Care Trust (UK)

Sponsor details

c/o Professor Alistair Burns
2nd Floor ERC
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)1612915886
alistair.burns@manchester.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Lundbeck Ltd £53,000 (study grant) plus £5,350 (laboratoty costs) = £58,350

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

2009 results in http://www.ncbi.nlm.nih.gov/sites/pubmed/19370737

Publication citations

Additional files

Editorial Notes