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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

NCTNCT01537549 (opens ClinicalTrials.gov in a new tab)Other idIRB1006011088
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glutathione, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
11 participants (actual)
Sponsor
Weill Medical College of Cornell University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
14 Sept 2010
Primary completion
24 Sept 2013
Completion
7 Apr 2015
First posted
23 Feb 2012 (estimated)
Last update posted
30 May 2017
Conditions
Progressive Supranuclear Palsy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013201420152016
  1. Ph 1/2

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

    NCT01537549

    14 Sept 2010 to 7 Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • alpha-lipoic acid and L-acetyl carnitineDrug

Arms1

  • Experimental

    Juvenon

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Adverse Events

    Time frame · at 25 weeks

    Registry description

    Incidence and severity of adverse events

Secondary outcomes(1)

  1. Cerebral Oxidative Stress Markers

    Time frame · at baseline and at week 5

    Registry description

    changes of cerebral lactate and glutathione levels as determined by magnetic resonance spectroscopy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· at 25 weeks

Adverse Events

GroupValue (Number of Adverse Events)
Juvenon23
Secondary and other outcome results(1)
Secondary outcomeMean· at baseline and at week 5

Cerebral Oxidative Stress Markers

GroupValue (Ratio)Spread
Juvenon at Baseline41.67
Juvenon at 1 Month4.61.41

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Juvenonalpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months–1 / 119 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

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