Multiple System Atrophy - Cerebellar Subtype (MSA-C) Clinical Trial
Official title:
Pathogenesis and Diagnosis of Multiple System Atrophy (MSA): PET Study of Neurochemical and Autonomic Disorders in MSA
| NCT number | NCT02035761 |
| Other study ID # | NS044233 |
| Secondary ID | NS044233 |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2011 |
| Est. completion date | September 2018 |
| Verified date | November 2018 |
| Source | University of Michigan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA
there is degeneration (progressive loss) of nerve cells in several brain and spinal cord
regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia,
incoordination, falls, slowness) to autonomic (fainting, bladder incontinence, sexual
dysfunction) to sleep problems (dream enactment, sleep apnea).
This research aims to help us better understand the patterns and timing of nerve degeneration
relatively early in the disease, and how this affects symptoms and progression. For instance:
1. Does MSA affect certain nerves that stimulate heart pumping? If so, does the severity of
loss of heart nerves affect disease progression and survival?
2. It is thought that MSA does not affect memory and thinking much, unlike other diseases
(such as Parkinson's). Is this accurate? Is there loss of nerves that transmit
acetylcholine (a neurochemical important in mental functioning)?
3. What can we learn about mood and sleep in MSA, through visualizing the serotonin system
in the brain? How does this relate to symptoms that subjects report in these often
underappreciated areas?
To answer these and other questions, investigators will take images of specific nerves in the
brain and heart using Positron Emission Tomography (PET) scans. Such imaging gives us
information that cannot be obtained from MRIs and CT scans. We will measure the levels of
several nerve cell types: serotonin, acetylcholine, and norepinephrine. Subjects will also
have many standardized assessments including quality-of-life and symptom assessments,
neurological examination, autonomic assessments, neuropsychological assessments, coordination
tests, and even assessments of vision and sense of smell. By pooling these results from many
MSA patients, and comparing with other diseases (such as Parkinson's disease) we hope to gain
a better understanding of what is happening early in MSA. Such knowledge could be very
valuable in future efforts to develop better therapies in this rare disease.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | September 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 80 Years |
| Eligibility |
Inclusion Criteria: Participants aged 30-80 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) Participants who are less than 4 years from the time of documented MSA diagnosis Participants who are willing and able to give informed consent "Normal" cognition as assessed by Mini Mental State Examination Exclusion Criteria: Pregnant or lactating females Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect the results of the study. These include conditions causing significant CNS or autonomic dysfunction, including congestive heart failure, recent (<6 months) myocardial infarction, thrombocytopenia (<50 x 10(9)/L), immunosuppressed state, severe uncontrolled hypertension, severe cardiopulmonary disease, severe anemia (hemoglobin <8g/dl), severe liver or kidney disease (creatinine >2.3 mg/dl) uncontrolled diabetes mellitus (HbA1c >10g%), alcoholism, malignant neoplasms, amyloidosis, uncontrolled hypothyroidism, unstable peripheral neuropathies, concurrent infections, orthopedic problems that compromise mobility and activities of daily living, severe cerebrovascular accidents (causing symptoms such as hemiplegia, aphasia and non-dominant parietal lobe syndrome), and neurotoxins or neuroactive drug exposure, parkinsonism due to drugs (including neuroleptics, L-methyldopa, reserpine, metoclopramide). Females who are pregnant Subjects known to have porphyria The regular use of neuroleptics within the six months prior to the initial evaluation. Occasional use of a neuroleptic as an anti-emetic in the past is allowed, providing not more than three doses were taken within the previous 12 months Diseases more consistent with Lewy Body dementia, progressive supranuclear palsy, essential tremor, inherited cerebellar degeneration, or postencephalitic parkinsonism Subjects receiving psychostimulants, antimuscarinics (trihexphenidyl, benztropine, and tricyclic antidepressants), acetylcholinesterase inhibitors, trazodone or modafinil will be excluded as they may interfere with study measures. Subjects with prior exposure to disallowed medications may be eligible if there has been an interval of > 2months for these medications, at the discretion of the investigators Dementia (DSM-IV criteria - Amer. Psych. Association, 1994). The score on the Mini-Mental State Examination must be >24 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan - Department of Neurology | Ann Arbor | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cardiac denervation | Early MSA patients vary in their degree of cardiac denervation. A greater degree of cardiac denervation is associated with greater baseline impairment of autonomic, visual and olfactory functions, and predicts a more rapid decline of these functions as well as motor performance. | 1 time | |
| Secondary | MSA Rate of Progression | To determine whether MSA subjects differ in progression rates based upon the relative timing of autonomic failure, particularly cardiac denervation. | 1 time |