Overview

Overview

The Lou Ruvo Center for Brain Health in Cleveland conducts clinical trials to advance new treatments for symptom management and disease modification in patients with Alzheimer’s disease, Parkinson’s disease, and mild cognitive impairment. The center’s clinical trial program has conducted more than 20 studies and enrolled more than 200 participants. The center has been involved in multiple clinical trials including:

  1. Neuronix
  2. Starbeam (MC)
  3. Starbeam (LW)
  4. Starbeam Ext
  5. Headway
  6. Headway Ext
  7. Grifols
  8. RVT-102 VH
  9. RVT-102 RBH
  10. RVT-102 OLE
  11. Rasagiline (MC)
  12. Rasagiline (LW)
  13. EARLY
  14. TRIAD
  15. Tango
  16. Mission (MC)
  17. Mission (LW)
  18. Engage
  19. SUVN-502
  20. Delphia*
  21. BAN2401*
  22. EIP19-NFD-501*
  23. Donepezil*
  24. Discover*
  25. Graduate*

*Currently Recruiting

Contact Information:

Babak Tousi, MD
batous@ccf.org

Kasia Rothenberg, MD
rothenk@ccf.org

Stephen Rao, PhD
raos2@ccf.org

James Leverenz, MD
leverj@ccf.org

Publications

Publications

Increased caffeine intake leads to worsening of electrocorticographic epileptiform discharges as recorded with a responsive neurostimulation device. MJ, Krishnan B, Bingaman WE, Najm IM, Alexopoulos AV, Nair DR. Clin Neurophysiol . 2016 Jun;127(6):2341-2. doi: 10.1016/j.clinph.2016.03.012. Epub 2016 Mar 18. No abstract available. PMID:  27178850.

Neuronix:

Repetitive transcranial magnetic stimulation (rTMS) combined with cognitive training is a safe and effective modality for the treatment of Alzheimer’s disease: clinical experience. Rabey JM, Dobronevsky E. J Neur Transm. 2016 Dec; 123(12): 1449-1455. doi: https://doi.org/10.1007/s00702-016-1606-6. Epub 2016 Sep 8. PMID: 27631152.

Starbeam:

Effect of Idalopirdine as adjunct to cholinesterase inhibitors on change in cognition in patients with Alzheimer disease: Three randomized clinical trials. Atri A, Frölich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL., JAMA. 2018 Jan 9; 319(2): 130-142. doi: https://doi.org/10.1001/jama.2017.20373. PMID: 29318278.

Grifols:

Plasma exchange for Alzheimer’s disease management by albumin replacement (AMBAR) trial: Study design and progress. Boada M, López O, Nuñez L, Szczepiorkowski ZM, Torres M, Grifols C, Páez A., Alzheimer’s Dement (NY). 2019 Feb 26; 5:61-69. doi: https://doi.org/10.1016/j.trci.2019.01.001. Epub 2019. PMID: 30859122.

Tango:

A randomized, single ascending dose study of intravenous BIIB092 in healthy participants. Qureshi IA, Tirucherai G, Ahlijanian MK, Kolaitis G, Bechtold C, Grundman M., Alzheimers Dement (NY). 2018 Dec; 17(4): 746-755. doi: https://doi.org/10.1016/j.trci.2018.10.007. Epub 2018. PMID: 30581980.

Mission:

Investigational BACE inhibitors for the treatment of Alzheimer’s disease. Imbimbo BP, Watling M., Expert Opin Inv Drug. 2018 Nov; 28(11):967-975. 10.1080/13543784.2019.1683160. Epub 2019 Oct 29. PMID: 31661331.

Engage:

Clinical development of Aducanumab, an Anti-Aβ human monoclonal antibody being investigated for the treatment of early Alzheimer’s disease. Budd Haeberlein S, O’Gorman J, Chiao P, Bussière T, von Rosenstiel P, Tian Y, Zhu Y, von Hehn C, Gheuens S, Skordos L, Chen T, Sandrock A. , J Prev Alzheimers Dis. 2017; 4(4): 255-263. https://doi.org/10.14283/jpad.2017.39. PMID: 29181491.

Question EMERGE as Biogen claims aducanumab turnaround.Howard R, Liu KY., Nat Rev Neurol. 2019 Nov; In Press. doi: 10.1038/s41582-019-0295-9. Epub 2019 Nov 29. No abstract available. PMID: 31784690.

SUVN-502:

SUVN-502, a novel, potent, pure, and orally active 5-HT6 receptor antagonist: pharmacological, behavioral, and neurochemical characterization. Nirogi R, Abraham R, Benade V, Medapati RB, Jayarajan P, Bhyrapuneni G, Muddana N, Mekala VR, Subramanian R, Shinde A, Kambhampati R, Jasti V., Behav Pharmacol. 2019 Feb; 30(1): 16-35. https://doi.org/10.1097/FBP.0000000000000414. PMID: 29847336.

BAN2401:

The path forward in Alzheimer’s disease therapeutics” Re-evaluating the amyloid cascade hypothesis. Tolar M, Abushakra S, Sabbagh M., Alzheimers Dement. 2019 Nov 4; In Press. https://doi.org/10.1016/j.jalz.2019.09.075. PMID: 31706733.

EIP19-NFD-501:

An exploratory clinical study of p38a kinase inhibition in Alzheimer’s disease. Scheltens P, Prins N, Lammertsma A, Yaqub M, Gouw A, Wink AM, Chu HM, van Berckel BNM, Alam  J., Ann Clin Transl Neurol. 2018 Mar 6; 5(4): 464-473. doi: 10.1002/acn3.549. Epub 2018 Apr. PMID: 29687023.

Donepezil:

Donepezil for dementia due to Alzheimer’s disease. Birks JS, Harvey RJ., Cochrane Database Syst Rev. 2018 Jun 18; doi: https://doi.org/10.1002/14651858.CD001190.pub3. PMID: 29923184.

Graduate:

A phase III randomized trial of gantenerumab in prodromal Alzheimer’s disease. Ostrowitzki S, Lasser RA, Dorlinger E, Scheltens P, Barkhof F, Nikolcheva T, Ashford E, Retout S, Hofmann C, Delmar P, Klein G, Andjelkovic M, Dubois B, Boada M, Blennow K, Santarelli L, Fontoura P, SCarlet RoAD Investigators. Alzheimers Res Ther. 2017 Dec 9; 9(1):95. doi: https://doi.org/10.1186/s13195-017-0318-y. PMID: 29221491.

Members & Collaborations

Members & Collaborations

Cleveland Clinic

  • Babak Tousi, MD
    Neuronix, Starbeam (LW), Starbeam Ext, Headway, Headway Ext, Grifols, RVT-102 VH, RVT-102 RBH, RVT-102 OLE, Rasagiline (LW), EARLY, TRIAD, Tango, Mission (MC), Mission (LW), Engage, Graduate, Delphia, BAN2401, EIP19-NFD-501
  • Kasia Rothenberg, MD
    SUVN-502
  • James Leverenz, MD
    Starbeam (MC), Rasagiline (MC), Discover
  • Stephen Rao, PhD
    Donepezil