Namenda (Memantine) for Non-motor Symptoms in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effects of Memantine on non-motor symptoms in patients with Parkinson's
      disease.

      Parkinson's disease (PD) affects about one million people in the United States. It is a
      common neurological condition that is clinically defined by rigidity (muscle stiffness),
      bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals
      numerous non-motor symptoms that have been underemphasized. Problematic symptoms include
      varying degrees of dementia, psychosis, diminished assertiveness and confidence, general
      fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder,
      and a common yet difficult to define sense of "not feeling well".
    

Detailed description: 
      Patients were enrolled over 11 months from the Parkinson Disease Center and Movement Disorder
      Clinic at Baylor College of Medicine. PD was diagnosed using standard criteria. Specific
      inclusion criteria were intentionally broad and included both fluctuating and non-fluctuating
      patients with a UPDRS "motivation" (#4) score of greater or equal to 2. Patients with
      dementia (MMSE<24) or taking amantadine were excluded.

      The patients signed an informed consent approved by the Baylor College of Medicine
      Institutional Review Board and the study was registered on Clinical Trials.gov #NCT00646204.
      The study was funded by a grant from the Forest Research Institute.

      After baseline assessments, patients (N=40) were randomized equally to drug (N=20) and
      placebo (N=20) groups. This was done by a computerized random number generator by a
      coordinator not otherwise involved in the study.

      Patients completed medical and medication histories, a Unified Parkinson's Disease Rating
      Scale (UPDRS), a battery of neuropsychiatric assessments (see Table 2), global impressions,
      and adverse events. Patients were not allowed to change other PD medications. The
      drug/placebo dosing began at 5 mg/day and increased to 5 mg 2x/day, 10 mg / 5 mg, and finally
      10 mg 2x/day, in weekly increments. After a safety call (2 weeks after initiation) they
      returned for identical assessments at week 8. Drug accountability was documented at each
      visit. An 8-week open label extension was started if desired using the same protocol and
      assessments.

      Tabulations and univariate statistics on difference scores between visits were run using
      Intercooled Stata V8.0 for windows (Stata Corporation, College Station, Texas 77845), and
      included Student's t-test with equal variances and contingency table analysis using Pearson's
      Chi-square test. Statistics were done using LOCF. Corrections for multiple comparisons were
      not done.
    

Intervention name(s): Memantine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg bid; 2 tabs bid
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; non-motor symptoms