Essential Amino Acids and Parkinsons Disease

NCT06604065 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: EAAPD1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Parkinson's 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Muscle Protein Synthesis

  Mixed muscle protein synthesis expressed as the fractional synthetic rate.

  4 hours

Secondary Outcomes (10)

• Whole body protein breakdown

  6 hours

• Whole body protein synthesis

  6 hours

• Plasma concentrations of amino acids

  8 hours

• Plasma concentrations of kynurenine

  6 hours

• Plasma concentrations of homovanillic acid (HVA)

  6 hours

Study Arms (2)

AMS2434 (amino acids)

EXPERIMENTAL

Product AMS2434. A single dose providing 10g of essential amino acids (EAAs). Study products will be in powder form and packaged in individual serving sizes and will be dissolved in 8 oz water for consumption.

Drug: AMS2434 (amino acids)

Placebo

PLACEBO COMPARATOR

Matched non-caloric placebo. Study products will be in powder form and packaged in individual serving sizes and will be dissolved in 8 oz water for consumption.

Drug: Placebo

Interventions

Placebo DRUG

Matched non-caloric placebo. Study products will be in powder form and packaged in individual serving sizes and will be dissolved in 8 oz water for consumption.

Placebo

AMS2434 (amino acids) DRUG

The proprietary composition includes leucine, valine, isoleucine, lysine, phenylalanine, threonine, tyrosine, histidine, and methionine. Small amounts of non-caloric flavorings are also included.

Also known as: Amino Acids

AMS2434 (amino acids)

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 years or older
• Clinical diagnosis of idiopathic Parkinson Disease
• Hoehn and Yahr stage 2-3
• Stable medication regimen with L-DOPA/carbidopa for at least 4 weeks prior to study entry

You may not qualify if:

• Findings suggestive of atypical or secondary Parkinsonism, including cerebellar sign
• Use of anticoagulation drugs (including aspirin and Plavix) within one week of the protocol
• Allergy to lidocaine
• Supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs
• Multiple strokes with stepwise progression of symptoms
• Neuroleptic treatment at time of study entry or time of onset of Parkinsonism
• Inability to walk without a cane or walker
• Deep brain stimulation
• Montreal Cognitive Assessment (MoCA) score \<18
• Use of investigational drugs
• Early Alzheimer's disease
• Frontotemporal dementia of dementia with Lewy bodies
• Major depression treated with SSRIs
• Individuals with auditory or visual hallucinations
• Individuals taking drugs that cause Parkinsonism like symptoms such as antipsychotics, anti-emetics, prokinectic and anti-seizure medications

Sponsors & Collaborators

• University of Arkansas: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Robert R Wolfe, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: March 9, 2026
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share