Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy

NCT01537549 | Completed Phase 1 Results

• 1 other identifier: IRB1006011088
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that alpha-lipoic acid and L-acetyl carnitine may have some neuroprotective activities and it is hoped that they could be helpful for people with neurodegenerative illnesses such as progressive supranuclear palsy (PSP). The purpose of this study is to find out whether the nutritional supplement alpha-lipoic acid/L-acetyl carnitine is safe and well-tolerated in individuals with PSP when given daily, and whether it affects their well-being, brain scan measurements and blood tests that measure the energy metabolism in cells.

Conditions

Progressive Supranuclear Palsy

Keywords

Progressive supranuclear palsy; alpha-lipoic acid; L-acetyl carnitine; antioxidant; magnetic resonance spectroscopy; neurodegeneration; glutathione

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Incidence and severity of adverse events

  at 25 weeks

Secondary Outcomes (1)

• Cerebral Oxidative Stress Markers

  at baseline and at week 5

Study Arms (1)

Juvenon

EXPERIMENTAL

Drug: alpha-lipoic acid and L-acetyl carnitine

Interventions

alpha-lipoic acid and L-acetyl carnitine DRUG

alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months

Also known as: Juvenon

Juvenon

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of probable PSP by NINDS/PSP workshop criteria (see patient folder)
• Age 40-75 years
• Able to undergo MRI
• Absence of significant medical, psychiatric, and other neurological disease
• Stable intake of supplements and medication

You may not qualify if:

• Failure to meet probable PSP diagnosis by NINDS/PSP workshop criteria
• unable to comply with informed consent process
• unable to undergo MRI
• presence of significant medical, psychiatric (incl MDD) or other neurological (incl epilepsy, brain tumor, stroke) disease
• possibility of pregnancy (negative test required in women of childbearing age)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Nerve Degeneration

Interventions

Thioctic Acid; Acetylcarnitine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Results Point of Contact

• Title: Dr. Claire Henchcliffe
• Organization: Weill Cornell Medicine

clh2007@med.cornell.edu

2127462584

Study Officials

• Claire Henchcliffe, MD DPhil

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: February 23, 2012
• Study Start: September 14, 2010
• Primary Completion: September 24, 2013
• Study Completion: April 7, 2015
• Last Updated: May 30, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-04

Locations

US (1)