Namenda (Memantine) for Non-motor Symptoms in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Memantine; placebo
Intervention description: 10 mg bid; 2 tabs bid
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson's disease; non-motor symptoms

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".
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be between the ages of 18 and 80 inclusive.

          2. Each subject must meet standard criteria for PD.

          3. All patients on dopaminergic therapy must report benefit. -No other abnormal
             neurological signs. -No direct or indirect trauma to the nervous system within 3
             months preceding the onset of PD. -No convincing evidence of sudden onset or evidence
             of stepwise deterioration.

          4. Subjects must be in generally good health as evidenced by previous medical history and
             clinical examination.

          5. Subjects will be allowed to take any PD medication with the exception of amantadine.
             They will also be allowed to take medications approved for the use of Alzheimer's
             disease.

          6. Subjects will be required to be on a stable dose of all medications for at least two
             weeks prior to entry into the study and may not alter these medications throughout the
             study.

          7. If subjects are on an anti-depressant medications, a stable dose of these will be
             required for at least six weeks prior to entry into the study.

          8. Subjects must be accessible by telephone.

          9. If the subject is a female of childbearing age, she must have had: a hysterectomy, or
             tubal ligation, or otherwise be incapable or pregnancy, or have practiced one of the
             following methods of contraception for at least one month prior to study entry:
             hormonal contraceptives, spermicide and barrier, intrauterine device, partner
             sterility.

         10. Female of childbearing age must have had a negative urine pregnancy test within one
             week of study entry. 11. Prior to participation in this study, each subject must sign
             an informed consent.

        Exclusion Criteria:

          1. Subjects who do not meet inclusion criteria.

          2. Subjects who are not able to abstain from alcohol for 24 hours prior to each
             evaluation.

          3. Subjects who can not maintain an identical dose of any medicine that may affect PD
             symptoms or signs during their entire study involvement.

          4. Subjects who have exhibited meaningful psychiatric disease not thought to be related
             to PD. (Depression and psychosis typical for PD will not be excluded). 5. Subjects who
             have previously taken memantine.

        6. Subjects currently taking Amantadine. 7. Subjects with greater than moderate dementia
        (MMSE<24). 8. Subjects with co-morbid disease that in the investigators decision could
        interfere with treatment with memantine.