A multi-center screening trial of rasagiline in patients with amyotrophic lateral sclerosis: Possible mitochondrial biomarker target engagement

Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

Volumn 16, Issue 5-6, 2015, Pages 345-352

  Macchi, Zachary ^a   Wang, Yunxia ^a   Moore, Dan ^b   Katz, Jonathan ^b   Saperstein, David ^c   Walk, David ^d   Simpson, Ericka ^e   Genge, Angela ^f   Bertorini, Tulio ^g   Fernandes, J Americo ^h   Swenson, Andrea ⁱ   Elman, Lauren ^j   Dimachkie, Mazen ^a   Herbelin, Laura ^a   Miller, Joann ^a   Lu, Jianghua ^a   Wilkins, Heather ^a   Swerdlow, Russell H ^a   Statland, Jeffrey ^a   Barohn, Richard ^a  

^a UNIVERSITY OF KANSAS MEDICAL CENTER   (United States)

^b CALIFORNIA PACIFIC MEDICAL CENTER   (United States)

^c Phoenix Neurological Assoc   (United States)

^d UNIVERSITY OF MINNESOTA   (United States)

^e HOUSTON METHODIST HOSPITAL   (United States)

^f MCGILL UNIVERSITY   (Canada)

^g UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^h UNIVERSITY OF NEBRASKA AT OMAHA   (United States)

ⁱ UNIVERSITY OF IOWA HEALTH CARE   (United States)

^j UNIVERSITY OF PENNSYLVANIA   (United States)

more..

Author keywords

apoptosis; Biomarker; clinical trials; mitochondria; rasagiline

Indexed keywords

BIOLOGICAL MARKER; PROTEIN BAX; PROTEIN BCL 2; RASAGILINE; RILUZOLE; INDAN DERIVATIVE; NEUROPROTECTIVE AGENT;

ADULT; ALOPECIA; AMYOTROPHIC LATERAL SCLEROSIS; ANXIETY DISORDER; APOPTOSIS; ARTICLE; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; DETERIORATION; DIZZINESS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TREATMENT FAILURE; FEMALE; HUMAN; HYPERTENSION; MALE; MITOCHONDRIAL MEMBRANE POTENTIAL; MULTICENTER STUDY; NAUSEA; OXIDATIVE STRESS; PRIORITY JOURNAL; PROSPECTIVE STUDY; TIME TO TREATMENT; XEROSTOMIA; AGED; CLINICAL TRIAL; DRUG EFFECTS; METABOLISM; MIDDLE AGED; NONPARAMETRIC TEST; RETROSPECTIVE STUDY; TIME FACTOR; TREATMENT OUTCOME;

AGED; AMYOTROPHIC LATERAL SCLEROSIS; APOPTOSIS; BCL-2-ASSOCIATED X PROTEIN; FEMALE; HUMANS; INDANS; MALE; MEMBRANE POTENTIAL, MITOCHONDRIAL; MIDDLE AGED; NEUROPROTECTIVE AGENTS; OXIDATIVE STRESS; PROTO-ONCOGENE PROTEINS C-BCL-2; RETROSPECTIVE STUDIES; STATISTICS, NONPARAMETRIC; TIME FACTORS; TREATMENT OUTCOME;

EID: 84945116255     PISSN: 21678421     EISSN: 21679223     Source Type: Journal    
DOI: 10.3109/21678421.2015.1026826     Document Type: Article

References (39)

1. Miller RG, Mitchell JD, Moore DH. Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Cochrane Database Syst Rev. 2012; 3:C D001447.
2. Youdim MB, Gross A, Finberg JP. Rasagiline [N-propargyl-1R(+)-aminoindan], a selective and potent inhibitor of mitochondrial monoamine oxidase B. Br J Pharmacol. 2001; 132: 500-6.
3. Chen JJ, Swope DM. Clinical pharmacology of rasagiline: a novel, second-generation propargylamine for the treatment of Parkinsons disease. J Clin Pharmacol. 2005; 45: 878-94.
4. Maruyama W, Akao Y, Youdim MB, Davis BA, Naoi M. Transfection-enforced Bcl-2 overexpression and an anti-Parkinsons drug, rasagiline, prevent nuclear accumulation of glyceraldehyde-3-phosphate dehydrogenase induced by an endogenous dopaminergic neurotoxin, N-methyl®salsolinol. J Neurochem. 2001; 78: 727-35.
5. Maruyama W, Youdim MB, Naoi M. Antiapoptotic properties of rasagiline, N-propargylamine-1®-aminoindan, and its optical (S)-isomer, TV1022. Ann N Y Acad Sci. 2001; 939: 320-9.
6. Waibel S, Reuter A, Malessa S, Blaugrund E, Ludolph AC. Rasagiline alone and in combination with riluzole prolongs survival in an ALS mouse model. J Neurol. 2004; 251: 1080-4.
7. Drory V. Evalutation of treatment with rasagiline in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2007; (Suppl 1): 145.
8. Menzies FM, Ince PG, Shaw PJ. Mitochondrial involvement in amyotrophic lateral sclerosis. Neurochem Int. 2002; 40: 543-51.
9. Gordon PH, Moore DH, Miller RG, Florence JM, Verheijde JL, Doorish C, et al. Efficacy of minocycline in patients with amyotrophic lateral sclerosis: a phase III randomized trial. Lancet Neurol. 2007; 6: 1045-53.
10. Cudkowicz ME, Shefner JM, Schoenfeld DA, Zhang H, Andreasson KI, Rothstein JD, et al. Trial of celecoxib in amyotrophic lateral sclerosis. Ann Neurol. 2006; 60: 22-31.
11. Aggarwal SP, Zinman L, Simpson E, McKinley J, Jackson KE, Pinto H, et al. Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled trial. Lancet Neurol. 2010; 9: 481-8.
12. Kaufmann P, Thompson JL, Levy G, Buchsbaum R, Shefner J, Krivickas LS, et al. Phase II trial of CoQ10 for ALS finds insufficient evidence to justify phase III. Ann Neurol. 2009; 66: 235-44.
13. Shefner JM, Cudkowicz ME, Schoenfeld D, Conrad T, Taft J, Chilton M, et al. A clinical trial of creatine in ALS. Neurology. 2004; 63: 1656-61.
14. Miller R, Bradley W, Cudkowicz M, Hubble J, Meininger V, Mitsumoto H, et al. Phase II/III randomized trial of TCH346 in patients with ALS. Neurology. 2007; 69: 776-84.
15. Gordon PH, Cheung YK, Levin B, Andrews H, Doorish C, Macarthur RB, et al. A novel, efficient, randomized selection trial comparing combinations of drug therapy for ALS. Amyotroph Lateral Scler Other Motor Neuron Disord. 2008; 9: 212-22.
16. Miller RG, Moore DH, Forshew DA, Katz JS, Barohn RJ, Valan M, et al. Phase II screening trial of lithium carbonate in amyotrophic lateral sclerosis: examining a more efficient trial design. Neurology. 2011; 77: 973-9.
17. Brooks BR, Miller RG, Swash M, Munsat TL., World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000; 1: 293-9.
18. Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999; 169: 13-21.
19. Kaufmann P, Levy G, Montes J, Buchsbaum R, Barsdorf AI, Battista V, et al. Excellent inter-rater, intra-rater, and telephone-administered reliability of the ALSFRS-R in a multicenter clinical trial. Amyotroph Lateral Scler. 2007; 8: 42-6.
20. Qureshi M, Schoenfeld DA, Paliwal Y, Shui A, Cudkowicz ME. The natural history of ALS is changing: improved survival. Amyotroph Lateral Scler Frontotemporal Degener. 2009; 10: 324-31.
21. Guthrie HD, Welch GR. Determination of high mitochondrial membrane potential in spermatozoa loaded with the mitochondrial probe 5,5,6,6-tetrachloro-1,1,3,3-tetraethylbenzimidazolyl-carbocyanine iodide (JC-1) by using fluorescence-activated flow cytometry. Methods Mol Biol. 2008; 477: 89-97.
22. Kuznetsov AV, Kehrer I, Kozlov AV, Haller M, Redl H, Hermann M, et al. Mitochondrial ROS production under cellular stress: comparison of different detection methods. Anal Bioanal Chem. 2011; 400: 2383-90.
23. Jetzek-Zader M, Gudowius S, Feyen O, Stevens M, Lipfert P, Niehues T. A single intravenous dose of prednisolone induces phosphatidylserine externalization, loss of surface marker expression and a 24-h net increase in human peripheral blood lymphocytes ex vivo. Rheumatol Int. 2007; 27: 667-73.
24. de Siqueira EC, Souza FT, Diniz MG, Gomez RS, Gomes CC. Hsp27 (HSPB1) differential expression in normal salivary glands and pleomorphic adenomas and association with an increased Bcl2/Bax ratio. Tumour Biol. 2014; 36: 213-7.
25. Cao G, Prior RL. Comparison of different analytical methods for assessing total antioxidant capacity of human serum. Clin Chem. 1998; 44: 1309-15.
26. Kollewe K, Mauss U, Krampfl K, Petri S, Dengler R, Mohammadi B. ALSFRS-R score and its ratio: a useful predictor for ALS progression. J Neurol Sci. 2008; 275: 69-73.
27. Bozik ME, Mitsumoto H, Brooks BR, Rudnicki SA, Moore DH, Zhang B, et al. A post hoc analysis of subgroup outcomes and creatinine in the phase III clinical trial (EMPOWER) of dexpramipexole in ALS. Amyotroph Lateral Scler Frontotemporal Degener. 2014; 15: 406-13.
28. Minguez-Minguez S, Solis-Garcia del Pozo J, Jordan J. Rasagiline in Parkinsons disease: a review based on meta-analysis of clinical data. Pharmacol Res. 2013; 74: 78-86.
29. Weiduschat N, Mao X, Hupf J, Armstrong N, Kang G, Lange DJ, et al. Motor cortex glutathione deficit in ALS measured in vivo with the J-editing technique. Neurosci Lett. 2014; 570: 102-7.
30. Youdim MB, Weinstock M. Molecular basis of neuroprotective activities of rasagiline and the anti-Alzheimers drug TV3326 [(N-propargyl-(3R)aminoindan-5-YL)-ethyl methyl carbamate]. Cell Mol Neurobiol. 2001; 21: 555-73.
31. Youdim MB, Amit T, Falach-Yogev M, Bar Am O, Maruyama W, Naoi M. The essentiality of Bcl-2, PKC and proteasome-ubiquitin complex activations in the neuroprotective-antiapoptotic action of the anti-Parkinsons drug, rasagiline. Biochem Pharmacol. 2003; 66: 1635-41.
32. Swerdlow RH, Parks JK, Pattee G, Parker WD Jr. Role of mitochondria in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000; 1: 185-90.
33. Siklos L, Engelhardt J, Harati Y, Smith RG, Joo F, Appel SH. Ultrastructural evidence for altered calcium in motor nerve terminals in amyotropic lateral sclerosis. Ann Neurol. 1996; 39: 203-16.
34. Bowling AC, Schulz JB, Brown RH Jr, Beal MF. Superoxide dismutase activity, oxidative damage, and mitochondrial energy metabolism in familial and sporadic amyotrophic lateral sclerosis. J Neurochem. 1993; 61: 2322-5.
35. Fujita K, Yamauchi M, Shibayama K, Ando M, Honda M, Nagata Y. Decreased cytochrome c oxidase activity but unchanged superoxide dismutase and glutathione peroxidase activities in the spinal cords of patients with amyotrophic lateral sclerosis. J Neurosci Res. 1996; 45: 276-81.
36. Bannwarth S, Ait-El-Mkadem S, Chaussenot A, Genin EC, Lacas-Gervais S, Fragaki K, et al. A mitochondrial origin for frontotemporal dementia and amyotrophic lateral sclerosis through CHCHD10 involvement. Brain. 2014; 137: 2329-45.
37. Wong YC, Holzbaur EL. Optineurin is an autophagy receptor for damaged mitochondria in parkin-mediated mitophagy that is disrupted by an ALS-linked mutation. Proc Natl Acad Sci U S A. 2014; 111: E4439-48.
38. Mandel S, Weinreb O, Amit T, Youdim MB. Mechanism of neuroprotective action of the anti-Parkinsons drug rasagiline and its derivatives. Brain Res Brain Res Rev. 2005; 48: 379-87.
39. Shrivastava M, Vivekanandhan S, Pati U, Behari M, Das TK. Mitochondrial perturbance and execution of apoptosis in platelet mitochondria of patients with amyotrophic lateral sclerosis. Int J Neurosci. 2011; 121: 149-58.