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Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)

Information source: Helse Stavanger HF
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dementia Associated With Parkinson's Disease; Dementia With Lewy Bodies

Intervention: Memantine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Helse Stavanger HF

Official(s) and/or principal investigator(s):
Dag Aarsland, MD, PhD, Principal Investigator, Affiliation: Helse Stavanger HF

Summary

A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.

Clinical Details

Official title: A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Global Impression of Change

Secondary outcome:

MMSE

Alzheimer's QUick Test

Cognitive Drug Research test

Neuropsychiatric Inventory

Unified Parkinson's Disease Rating Scale, part III

Epworth Sleep Scale

Stavanger Sleep Scale

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- a diagnosis of Parkinson's disease (Larsen and Dupont, 1994) and dementia (DSM

IV(1987; 1994), or Dementia with Lewy bodies (McKeith et al. Neurology 2005)

- mild-to-moderate or moderate dementia (i. e. MMSE 12-26, inclusive)

- the subject has given a written informed consent

- the subject is able and willing to comply with the study procedures and has a

reliable caregiver (i. e. relative or nurse/nurse assistant who sees the patient at least weekly) Exclusion Criteria:

- other brain disease of sufficient severity to cause dementia

- mental retardation

- terminal illness with life expectancy shorter than 6 months

- recent major changes in health status

- known epilepsy or previous convulsive seizure

- major depression

- severe dementia as defined by a Mini-mental State Examination score of 12 or lower

- moderate to severe renal impairment (i. e. serum creatinine > 1,5 upper limit normal

(ULN) or creatinin clearance < 40ml/minute/1,73 m2

- moderate or severe heart disease (NYHA III-IV)

- moderate or severe pulmonal disease

- moderate to severe hepatic impairment (bilirubin or transaminases > 2 times ULN

- women of childbearing potential (i. e. not post-menopausal and not taking

contraceptive

- the subjects is lactating

- any laboratory value(s) exceeding the limits of normality if deemed to be clinically

relevant by the study physician

- known allergies to the investigational product

Locations and Contacts

Stavanger University Hospital, Old Age Psychiatry Clinic, Stavanger 4005, Norway

Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo, Malmo 20502, Sweden

King's COllege London, London SE1 1UL, United Kingdom

Mental Health Unit, Epping, Essex CM16 6TN, United Kingdom

Additional Information

Starting date: February 2006
Last updated: July 27, 2015

Page last updated: August 23, 2015

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