To evaluate the effects of Memantine on non-motor symptoms in patients with Parkinson's
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".
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
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
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
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.
1. Subjects who do not meet inclusion criteria.
2. Subjects who are not able to abstain from alcohol for 24 hours prior to each
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.