Mechanism classCompound (Trial)SponsorPhaseNPopulationDoseDurationPrimary endpointStatusNCTRef
Calcium channel blockerIsradipine (STEADY-PD III)NINDS/PSG/MJFFIII336>30 years, diagnosis <3 years, no DA rx5 mg twice daily vs placebo36 monthsΔUPDRS I-III at month 36Negative, no benefit on secondary outcomesNCT02168842[17]
Urate elevation/antioxidantInosine (SURE-PD3)NINDS/PSG/MJFFIII298>30 years, diagnosis <3 years, PD DaTscan, no DA rx (stable MAOB-I allowed), serum urate ≤5.7 mg/dLUp to 3 g/day, titrated to serum urate level 7.1–8.0 mg/dL24 monthsΔMDS-UPDRS I-III at month 24Negative, early terminationNCT02642393[18]
Statin/anti-inflammationSimvastatin (PD STAT)University Hospital Plymouth NHS TrustII23540–90 years, H&Y ≤ 3, on DA rx with wearing off40 mg daily for 1 month, then 80 mg24 months with 2 month washoutΔMDS-UPDRS III (OFF state) at month 24NegativeNCT02787590[19]
Iron chelationDeferiprone (SKY)ApoPharmaII14018–80 years, diagnosis <3 years, stable dose of DA rx300, 600, 900, or 1200 mg twice daily vs placebo9 monthsΔMDS-UPDRS I-III at month 9Study completed 9/2019, results pendingNCT02728843
Deferiprone (FAIRPARKII)ApoPharmaII372<80 years, disease duration <18 months, no DA rx15 mg/kg twice daily vs placebo36 weeksΔMDS-UPDRS I-III at week 36Active, not recruiting; estimated completion 4/2021NCT02655315
Glucagon-like peptide 1 agonistExenatideUniversity College, LondonII6025–75 years, on DA rx with wearing off phenomena2 mg sc once weekly vs placebo48 weeksΔMDS-UPDRS III (OFF state) at week 60Positive; ΔMDS-UPDRS III + 1.0 (exenatide) vs −2.1 (placebo) (p = 0.0318)NCT01971242[20]
Exenatide (Exenatide-PD3) ISRCTN14552789 (Vijiaratnam, 2021 #2793) ongoingUniversity College, LondonIII20025–80 years, on DA rx for >4 weeks2 mg sc weekly vs placebo96 weeksΔMDS-UPDRS I-III (OFF state) at week 96Recruiting; estimated completion 9/2023NCT04232969
ExenatideCenter for Neurology, StockholmII6025–80 years, H&Y ≤ 2 (ON), on levodopa2 mg sc weekly vs placebo18 monthsFDG-PET network analysisRecruiting, estimated completion 10/2022NCT04305002
SR-Exenatide (PT320) (sustained release)Peptron, Inc.II9940–75 years, diagnosis <24 months, stable dose of levodopa2 mg sc weekly vs 2.5 mg sc every 2 weeks vs placebo48 weeksΔMDS-UPDRS III at week 48Recruiting, estimated completion 12/2021NCT04269642
NLY01 (pegylated exenatide)Neuraly, Inc.II24030–80 years, PD DaTscan, no DA rx2.5 mg vs 5 mg sc weekly vs placebo36 weeksΔMDS-UPDRS II-III at week 36Recruiting; estimated completion 4/2021NCT04154072
Lixisenatide (LixiPark)University Hospital, ToulouseII15640–75 years, diagnosis <3 years, stable DA rx10 µg/day × 14 days, then 20 µg/day vs placebo12 monthsΔMDS-UPDRS III at month 12Active, not recruiting; estimated completion 12/2021NCT03439943
LiraglutideCedars-Sinai Medical CenterII5725–85 years, diagnosis >2 years, DA-responsive1.8 mg sc daily vs placebo54 weeksΔMDS-UPDRS III at weeks 28 and 54Recruiting, estimated completion 12/2021NCT02953665
c-Abl tyrosine kinase inhibitorNilotinib (NILO-PD)Northwestern University/PSG/MJFFII7640–79 years, diagnosis >5 years, stable DA rx150 mg or 300 mg once daily vs placebo6 monthsSafety and tolerabilitySafe and well-tolerated; low CSF exposure with no change in dopamine metabolitesNCT03205488[21]
Nilotinib (PD Nilotinib)Georgetown UniversityII7540–90 years, H&Y 2.5–3, stable DA rx150 mg or 300 mg once daily vs placebo12 monthsSafety and tolerabilityReasonably safe, increased CSF levels of DA metabolitesNCT02954978[22]
K0706 (PROSEEK)Sun PharmaII504>50 years, symptoms <3 years, PD DaTscan, no DA rxLow dose vs high dose once daily vs placebo40 weeksΔMDS-UPDRS II-III at week 40Recruiting, estimated completion 3/2023NCT03655236
c-Abl kinase inhibitors in development for PD: IkT-148009 (Inhibikase): vodobatinib (Ph2, SPARC), Radotinib HCl (Ph2, Il-yang), and FB-101 (Ph1, 1ST Bio);
GBAAmbroxolUniversity College, LondonII2340–80 years, H&Y 1–3, 1:1 with and without GBA1 mutationsEscalating dose to 1260 mg daily186 daysGCase, ambroxol levels in blood, CSFPositive; decrease in GCase activity by 19% (p = 0.04), increased CSF ambroxolNCT02941822[23]
AmbroxolLawson Health Research InstituteII75>50 years, mild to moderate dementia, H&Y 2–3.51050 mg daily vs placebo52 weeksΔADAS-cog, ADCS-CGIC at weeks 26 and 52Recruiting, estimated completion 12/2021NCT02914366
GZ/SAR402671 (MOVES-PD)Sanofi/GenzymeII27018–80 years, H&Y ≤ 2, PD-associated GBA1 mutation, stable DA rxPart 1: increasing dose once daily; part 2: determined in part 1Part 1: up to 48–66 weeks; part 2: 52-week rx, followed by 104 weeksPart 1: safety and tolerability; part 2: ΔMDS-UPDRS II-III at week 8 and 52Active, not recruiting; estimated completion 2/2024NCT02906020

Pittsburgh University

Greenamyre Lab

  • Questions

Tim Greenamyre, MD, PhD
Love Family Professor & Vice-Chair of Neurology
Chief, Movement Disorders Division
Director, Pittsburgh Institute for Neurodegenerative Diseases
E-MAIL

INTERESTS

Currently, treatments for neurodegenerative diseases are inadequate; they typically address symptoms rather than the underlying degenerative process. As a result, we have no way to alter the inexorable progression of these devastating illnesses. My Lab is interested in defining mechanisms of neurodegeneration in order to identify new targets for development of neuroprotective (‘disease-modifying’) therapeutic strategies. Most of our current work is on Parkinson’s disease (PD), and we are particularly interested in mitochondrial abnormalities and their roles in causing oxidative damage, protein aggregation and neurodegeneration.

About 90% of PD cases do not have a clear genetic cause and are therefore called ‘sporadic’ or ‘idiopathic’ cases. However, a large number of genetic mutations have been identified which can result in relatively rare inherited forms of the disease – and there are still other mutations which may not cause the disease, but greatly increase the risk of developing PD. Identification of such mutations has provided crucial clues about potential mechanisms that we are currently pursuing. We are particularly interested in the biological interactions between environmental exposures and genetic factors that increase disease risk.

Among other approaches, we are examining the potential benefits of ‘gene therapy’ approaches. Autosomal dominant mutations are generally thought to produce a detrimental ‘gain-of-function’ for the affected protein, so the general approach is to reduce expression of those harmful proteins. On the other hand, autosomal recessive mutations are associated with a loss of function, so in this instance, we attempt to increase expression of the wildtype (normal) protein.

We are also working to develop ‘biomarkers’ of PD, using blood samples, that will help us determine whether neuroprotective, disease-modifying therapies are doing what they are designed to do.

  • Susceptible PD population?
  • Mitochondrial DNA damage: molecular marker of vulnerable nigral neurons in Parkinson’s disease,
    • SN-specific 인데 어떻게 blood에서 상관?
    • Change over time?
    • 다른 mito dysfunction과의 관계? Ie is this the best mt marker?
    • Is it age-dependent in normal people?
Interested areaNot interested area
Genetic-environmental (toxin) interactionGenetics itself (PRS)
Blood cell based PD early diagnosis using mt DNA damage

Burton Lab

Edward A. Burton, MD, DPhil, FRCP

Berman Lab

Sarah B. Berman, MD, PhD

Dr. Berman’s research focuses on the role of mitochondria in neurodegenerative diseases, particularly Parkinson’s disease, and her laboratory is evaluating the role of mitochondrial dynamics in neurodegenerative diseases. Mitochondria, the energy-producing organelles in cells, are very dynamic in neurons, undergoing frequent division (fission) and fusion, and being transported in a regulated fashion. These processes are critical for synapse function and formation, programmed cell death mechanisms, and protection of mitochondrial DNA. Changes in mitochondrial dynamics are increasingly being linked to neurodegenerative diseases. However, these mitochondrial processes have been very difficult to study directly, particularly in the brain. Using novel methodology, Dr. Berman’s laboratory directly studies the role

Uncertain Spans

  • 표 좌측 일부 셀 (“c-Abl kinase inhibitors in development for PD” 행)이 단일 통합 행인지 일반 행에 끼어든 메모형 줄인지 사진만으로는 단정 어렵다. 본 전사에서는 colspan=12로 통합 처리했다.
  • 페이지 하단 Berman Lab 단락 마지막 문장은 사진 하단에서 “studies the role”에서 잘려 있어 다음 줄부터는 다음 사진으로 이어진다.
  • “Greenamyre Lab Questions” 아래 첫 줄 “Mitochondrial DNA damage: molecular marker of vulnerable nigral neurons in Parkinson’s disease,” 다음 두 글자 정도가 사진 우측 어두운 영역으로 잘렸을 가능성이 있어 마침표/물음표 여부를 확정하지 않았다.