Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604065
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Essential Amino Acids and Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Stimulation of Muscle Protein Synthesis with Essential Amino Acids in Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAAPD
Brief Summary:
Parkinsons disease is a neuromuscular disease that is relatively common in elderly that has many potentials symptoms including a variety of physical features that together reduce quality of life The Study Team have developed a nutritional supplement AMS2434 based on essential amino acids that targets improving muscle health and brain neurotransmitter balance This protocol will determine in individuals with PD the effect of AMS2434 on muscle protein synthesis neurotransmitter production and mood and cognition
Detailed Description:
Parkinsons disease PD is characterized by the loss of dopaminergic neurons in the substantia nigra and is the second most common neurodegenerative disease in older individuals PD may involve a variety of symptoms but the predominant manifestation is impaired physical function including muscle atrophy and weakness bradykinesia and reduced endurance Older PD patients frequently present with or develop greater loss of muscle mass than expected from aging alone sarcopenia Sarcopenia results in inactivity chronic inflammation and neurodegeneration all of which compound the loss of muscle function due to PD L-DOPAcarbidopa is the most common drug therapy for PD and can mitigate some of the physical problems with PD but progression of the disease usually ultimately results in severe reduction of quality of life
The metabolic basis for loss of muscle mass with sarcopenia is anabolic resistance defined as a diminished stimulation of muscle protein synthesis by dietary protein Reduced muscle protein synthesis in response to dietary protein consumption not only contributes to the loss of muscle mass but also to impaired single muscle fiber function decreased mitochondrial biogenesis and reduced neuromuscular junction stability all of which contribute to impaired physical function The consequences of anabolic resistance of muscle protein in PD is often compounded by the recommendation for reduced consumption of dietary protein due to the potential interference of absorbed dietary amino acids with the transport of L-DOPA from the intestine into the blood and from the blood into the brain
We have developed an EAA-based nutritional supplement called AMS2434 designed to stimulate muscle protein synthesis in older individuals with PD and to promote dopamine production in the brain AMS2434 is cleared rapidly from the blood after consumption thereby minimally interfering with the transport of L-DOPAcarbidopa In addition AMS2434 contains tyrosine to enhance the brain production of dopamine AMS2434 also decreases plasma tryptophan which in turn reduces its degradation product kynurenine which may be involved in the development of sarcopenia We have previously shown that a 10g dose of EAAs maximally stimulates muscle protein synthesis in healthy elderly In the current protocol we will determine if 10g of a mixture of a specifically designed mixture of EAAs AMS2434 will robustly stimulate muscle protein synthesis in anabolic resistant individuals with Parkinsons disease In addition we will determine if AMS2434 stimulates brain dopamine synthesis from tyrosine
The metabolic basis for loss of muscle mass with sarcopenia is anabolic resistance defined as a diminished stimulation of muscle protein synthesis by dietary protein Reduced muscle protein synthesis in response to dietary protein consumption not only contributes to the loss of muscle mass but also to impaired single muscle fiber function decreased mitochondrial biogenesis and reduced neuromuscular junction stability all of which contribute to impaired physical function The consequences of anabolic resistance of muscle protein in PD is often compounded by the recommendation for reduced consumption of dietary protein due to the potential interference of absorbed dietary amino acids with the transport of L-DOPA from the intestine into the blood and from the blood into the brain
We have developed an EAA-based nutritional supplement called AMS2434 designed to stimulate muscle protein synthesis in older individuals with PD and to promote dopamine production in the brain AMS2434 is cleared rapidly from the blood after consumption thereby minimally interfering with the transport of L-DOPAcarbidopa In addition AMS2434 contains tyrosine to enhance the brain production of dopamine AMS2434 also decreases plasma tryptophan which in turn reduces its degradation product kynurenine which may be involved in the development of sarcopenia We have previously shown that a 10g dose of EAAs maximally stimulates muscle protein synthesis in healthy elderly In the current protocol we will determine if 10g of a mixture of a specifically designed mixture of EAAs AMS2434 will robustly stimulate muscle protein synthesis in anabolic resistant individuals with Parkinsons disease In addition we will determine if AMS2434 stimulates brain dopamine synthesis from tyrosine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None