Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04428983
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2019-11-20
Brief Title:
The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinsons Disease
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinsons Disease
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parkinson disease PD is considered a multisystemic neurodegenerative disorder together with the classic motor disability and a number of non-motor symptoms NMSNMS have a significant negative relation with patients quality of life In general both medicinal and nonmedicinal therapies are often advised for PD patients with NMS but robust evidences for underpinning the clinical effects are limited Recently the search for small preventative neurotrophic compounds that are responsible for the maintenance survival of neurons has attracted much attention Erinacine A which is extracted from Hericium erinaceus is the one showed prominent beneficial effects in the central nervous system It can increase NGF and catecholamine content in the locus coeruleus and hippocampus of rats This markedly increases neuronal survival in different brain areas and substantially improve behavioral outcomes in various animal models In a MPTP-induced Parkinsonism model treatment with Hericium erinaceus mycelium reduced the loss of dopaminergic cell eliminated neuronal apoptosis and reversed MPTP-associated motor deficits Thus this project intends to hold a randomized controlled trial to assess the effect of Hericium erinaceus mycelium which is enriched of Erinacine A in NMS of PD This project will enroll 80 patients with PD Subjects will be randomly allocated into study or placebo group Subjects will take Hericium erinaceus mycelium for 2 years one capsule per meal per day and their treatments for PD will not be altered
Detailed Description:
Inclusion criteria
1 PD patients aged 50-79 years diagnosed by neurologist should exclude vascular parkinsonism secondary parkinsonism including toxin drug heavy metal CO intoxication normal pressure hydrocephalus multiple system atrophy progressive supranuclear palsy cortical basal degeneration dementia with Lewy Body hereditary parkinsons disease with genetic mutation Huntingtons disease Wilson disease spinal cerebellar ataxia with extrapyramidal syndrome essential tremor dystonia
2 PD at Hoehn and Yahr stage 2-25
3 without cognitive decline
Exclusion criteria
1 with diabetes mellitus DM
2 with nephropathy GFR 30mlmin
3 with significant neurological deficits caused by vascular insults
Measurement parameters
1 At recruitment blood sugar AST ALT BUN Crea Ca Na K and peripheral blood cell for the expression levels of KATP
2 every 6 months motor symptoms UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
3 every 1 year CASI tilting table AST ALT BUN crea Na K Ca
Protocol
0 month initial baseline
1 blood sugar AST ALT BUN Crea Ca Na K and peripheral blood cell
2 Tilting table test autonomic function
3 CASI cognitive test
4 UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
5 stool microbiota
6 months UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
12 months
1 UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
2 CASI cognitive test tilting table AST ALT BUN crea Na K Ca
18 months UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
24 months
1 UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
2 CASI cognitive test tilting table AST ALT BUN crea Na K Ca
3 stool microbiota
1 PD patients aged 50-79 years diagnosed by neurologist should exclude vascular parkinsonism secondary parkinsonism including toxin drug heavy metal CO intoxication normal pressure hydrocephalus multiple system atrophy progressive supranuclear palsy cortical basal degeneration dementia with Lewy Body hereditary parkinsons disease with genetic mutation Huntingtons disease Wilson disease spinal cerebellar ataxia with extrapyramidal syndrome essential tremor dystonia
2 PD at Hoehn and Yahr stage 2-25
3 without cognitive decline
Exclusion criteria
1 with diabetes mellitus DM
2 with nephropathy GFR 30mlmin
3 with significant neurological deficits caused by vascular insults
Measurement parameters
1 At recruitment blood sugar AST ALT BUN Crea Ca Na K and peripheral blood cell for the expression levels of KATP
2 every 6 months motor symptoms UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
3 every 1 year CASI tilting table AST ALT BUN crea Na K Ca
Protocol
0 month initial baseline
1 blood sugar AST ALT BUN Crea Ca Na K and peripheral blood cell
2 Tilting table test autonomic function
3 CASI cognitive test
4 UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
5 stool microbiota
6 months UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
12 months
1 UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
2 CASI cognitive test tilting table AST ALT BUN crea Na K Ca
18 months UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
24 months
1 UPDRS evaluate with UDYSRS if presence with dyskinesia Non motor symptoms self-report PDQ39 QUIP PDSS Rated by neurologist NMSS HAM-D BPRS
2 CASI cognitive test tilting table AST ALT BUN crea Na K Ca
3 stool microbiota
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None