N/A
N=37
Amyloidopathy, Cholinopathy, Dopamine Responsiveness and Freezing of Gait in PD
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03647137 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: L-DOPA Insensitivity — 5 Participants — p=0.00468
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Detailed motor testing, including FoG, in PD subjects (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY L-DOPA Insensitivity |
5 | 0.00468 sig |
| PRIMARY Striatal FEOVB PET Binding |
4.89; 5.01; 4.30; 4.06 | — |
| PRIMARY Striatal DTBZ PET Binding |
1.93; 1.76; 1.59; 1.76 | — |
| PRIMARY Striatal PIB PET Binding |
1.08; 1.15; 1.12; 1.02 | — |
| SECONDARY Serotonergic Innervation of Striatum and Freezing |
1.741856; 1.120202; 1.796165 | — |
Summary
Early stage Parkinson disease (PD) is characterized by a 'honeymoon' phase in terms of responsiveness of motor symptoms, including gait, to dopaminergic pharmacotherapy. Advancing PD is associated with disabling axial motor complications, such as freezing of gait (FoG), with decreased or even refractory dopamine responsiveness in over 50% of patients. The management of dopamine resistant gait problems represents the most important unmet need in PD. This study will related detailed motor testing to brain PET imaging to see if certain molecules (or lack thereof) involved with neurologic transmission in the brain are involved with FoG.
Eligibility Criteria
Inclusion Criteria
- PD based on the United Kingdom Parkinson's Disease Society Brain Bank
- Diagnostic Research Criteria with or without Freezing of Gait
- Duration of Disease > 5 years
- Mini-Mental State Examination (MMSE) > 23
Exclusion Criteria
- Dementia
- Dementia with Lewy Bodies
- Other disorders which may resemble PD
- Subjects on neuroleptic, anticholinergic (trihexyphenidyl, benztropine) or cholinesterase inhibitor drugs
- Evidence of a stroke or mass lesion on structural brain imaging (MRI)
- Participants in whom MRI is contraindicated including, but not limited to:
- those with a pacemaker
- presence of metallic fragments near the eyes or spinal cord
- cochlear implant
- Severe claustrophobia precluding MR or PET imaging
- Subjects limited by participation in research procedures involving ionizing radiation
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03647137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.