Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)

NCT06362707 | Recruiting Phase 2 DMC

• 1 other identifier: 2023161001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease. The main questions it aims to answer are:

• Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months?
• What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)?
• Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations.
• Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review. The study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET.

Conditions

Alzheimer Disease; Cognitive Decline, Mild

Keywords

Alzheimer Disease; Mild Cognitive Decline; Fasudil

Outcome Measures

Primary Outcomes (2)

• Cognition

  The primary outcome will be the FLAME computer-based working memory composite comprised of tests of working memory and episodic memory

  The cognitive battery will be performed at baseline and every three months until last visit, supported by trial staff (up to 1 year).

• Brain metabolism

  FDG-PET is a highly sensitive means of determining brain metabolism and has been accepted as a good proxy measure of synaptic function. Importantly, FDG-PET based measures of brain metabolism correlate well with cognitive decline in AD, better than amyloid plaques. Data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) study suggest that FDG PET has good power to detect a 25% treatment effect over 12 months

  The outcome will be change in FDG-PET between baseline and at 12 months.

Secondary Outcomes (23)

• Plasma levels of ptau217

  Collection of blood samples will occur at baseline and the 12-month visit.

• Plasma levels of nfl

  Collection of blood samples will occur at baseline and the 12-month visit.

• Levels of cerebrospinal Aβ1-40 and Aβ1-42

  Collection of CSF samples will occur at baseline and the 12-month visit.

• Levels of cerebrospinal tau and p-tau

  Collection of CSF samples will occur at baseline and the 12-month visit.

• Blood pressure (Safety assessments)

  Conducted at all visits throughout the 12-month duration of the study. Additionally, the Columbia Suicide Severity Rating Scale (C-SSRS) will be administered at screening, month 6, and month 12

Study Arms (2)

Fasudil

EXPERIMENTAL

In recognition that fasudil has only been evaluated in published studies for treatment durations of up to 3 months, we intend to enroll participants in three successive cohorts of 20, 50 and 130 people, respectively. Participants in the initial cohort will undergo a 2-week titration period (60 mg total daily dose; 20 mg tds) before being escalated to the maintenance dose (120 mg total daily dose; 40 mg tds) for up to 50 additional weeks of treatment. The selected dose of 120mg per day is optimized for potential efficacy over the planned 12-month treatment period, while providing a reasonable margin of safety based on available clinical and nonclinical data.

Drug: Fasudil

Placebo

PLACEBO COMPARATOR

Following screening procedures, subjects will be randomized at baseline to receive fasudil or matching placebo across all cohorts. 1:1 randomization will be performed.

Drug: Placebo

Interventions

Fasudil DRUG

A ROCK inhibitor approved for treating vasospasms following subarachnoidal bleeding in Japan and China. Dosage: Participants will undergo a 2-week titration period at 60 mg daily before escalating to a maintenance dose of 120 mg daily.

Fasudil

Placebo DRUG

Placebo tablets that look identical to the fasudil tablets and will follow the same dosing schedule as participants receiving fasudil.

Placebo

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), as recently defined by the FDA (2018; Figure 2)
• A significant change on a validated AD amyloid or tau biomarker (as determined either by visual reading of amyloid PET scans using any of the approved ligands, or CSF Aβ 1-42 levels or blood p-tau 217 cut-offs as determined by the clinical research laboratory)
• A CDR Global rating of 0.5 or 1.0 (Morris 1993) and have an MRI scan within the past two years that has no findings inconsistent with AD
• Capacity to give informed consent based on the clinical judgement of an experienced clinician
• The participant needs to have a reliable study partner with regular contact (a combination of face-to-face visits and telephone contact is acceptable) who has sufficient interaction with the participant to provide meaningful input into rating scales
• Age from 50 years
• Fluency in Norwegian and evidence of adequate premorbid intellectual functioning
• Capable of participating in all scheduled evaluations and complete all required tests
• Female participants must be of non-childbearing potential or have a negative serum pregnancy test within 14 days of baseline assessments and agree to the use of effective birth control throughout their participation in the study

You may not qualify if:

• Significant cerebrovascular disease, as indicated by clinical history, neurological examination, or on MRI (including cortical infarction or deep white matter or periventricular white matter hyperintensities with a Fazekas scale score of 3 (Fazekas et al 1987).
• A history of cerebrovascular bleeding or severe bleeding of the digestive tract, lungs, nose or skin
• Severe renal impairment (GFR \<30) or serum creatinine or urea nitrogen values ≥3 times Upper normal limit (ULN) at screening or baseline
• Moderate to severe hepatic impairment. Serum alanine transaminase (ALT) or aspartate transaminase levels ≥3 times ULN at screening or baseline
• Currently poorly controlled diabetes as indicated by HbA1c values \>9
• White blood cell (WBC) values \<3.5 K/μl
• History of paralytic ileus or current severe chronic constipation
• Known allergy to fasudil or established systemic inflammatory disease or autoimmune disease.
• Clinically significant hypotension defined by blood pressure values \<90/60 mmHg, regardless of the individual's sitting or standing position and associated with relevant clinical symptoms (e.g., tachycardia, dizziness, syncope)
• Current clinically significant depression or other mental disorder likely to affect cognition or interfere with study participation
• Recent (within 3 months) relevant medication changes. Participants must have been on stable anti-dementia (cholinesterase inhibitors or memantine) or anti-depressive medications for at least three months before the study
• Participants using sedating drugs, if unavoidable, will be excluded from the study. However, short-acting sleep medications can be used if taken as recommended and if the participant has maintained stability on them for a minimum of 3 months prior to the start of the study
• Participation in other drug trials
• Currently ongoing life-threatening disease, such as metastatic cancer, advanced cardiovascular disease, advanced respiratory disease, terminal kidney disease, or advanced stages of infectious diseases
• Any current or past neurological disease unrelated to Alzheimer's disease with cognitive sequelae

Sponsors & Collaborators

• Helse Fonna: collaborator
• St. Olavs Hospital: collaborator
• University Hospital, Akershus: collaborator
• Haraldsplass Deaconess Hospital: collaborator
• Helse Stavanger HF: lead
• University of Exeter: collaborator

Study Sites (6)

University Hospital of North Norway

Tromsø, Nordland, Norway

NOT YET RECRUITING

Akershus Hospital:

Oslo, Oslo, Norway

NOT YET RECRUITING

Haugesund Hospital

Haugesund, Rogaland, Norway

NOT YET RECRUITING

Stavanger University Hospital

Stavanger, Rogaland, Norway

RECRUITING

St. Olavs Hospital:

Trondheim, Trøndelag, Norway

NOT YET RECRUITING

Haraldsplass Deaconess Hospital

Bergen, Vestland, Norway

ENROLLING BY INVITATION

Related Publications (40)

• Asano T, Ikegaki I, Satoh S, Suzuki Y, Shibuya M, Takayasu M, Hidaka H. Mechanism of action of a novel antivasospasm drug, HA1077. J Pharmacol Exp Ther. 1987 Jun;241(3):1033-40.

  PMID: 3598899 BACKGROUND

• Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

  PMID: 29318278 BACKGROUND

• Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

  PMID: 31193334 BACKGROUND

• Ballard C, Aarsland D, Cummings J, O'Brien J, Mills R, Molinuevo JL, Fladby T, Williams G, Doherty P, Corbett A, Sultana J. Drug repositioning and repurposing for Alzheimer disease. Nat Rev Neurol. 2020 Dec;16(12):661-673. doi: 10.1038/s41582-020-0397-4. Epub 2020 Sep 16.

  PMID: 32939050 BACKGROUND

• Brooker H, Williams G, Hampshire A, Corbett A, Aarsland D, Cummings J, Molinuevo JL, Atri A, Ismail Z, Creese B, Fladby T, Thim-Hansen C, Wesnes K, Ballard C. FLAME: A computerized neuropsychological composite for trials in early dementia. Alzheimers Dement (Amst). 2020 Oct 14;12(1):e12098. doi: 10.1002/dad2.12098. eCollection 2020.

  PMID: 33088895 BACKGROUND

• Corbett A, Pickett J, Burns A, Corcoran J, Dunnett SB, Edison P, Hagan JJ, Holmes C, Jones E, Katona C, Kearns I, Kehoe P, Mudher A, Passmore A, Shepherd N, Walsh F, Ballard C. Drug repositioning for Alzheimer's disease. Nat Rev Drug Discov. 2012 Nov;11(11):833-46. doi: 10.1038/nrd3869.

  PMID: 23123941 BACKGROUND

• Couch BA, DeMarco GJ, Gourley SL, Koleske AJ. Increased dendrite branching in AbetaPP/PS1 mice and elongation of dendrite arbors by fasudil administration. J Alzheimers Dis. 2010;20(4):1003-8. doi: 10.3233/JAD-2010-091114.

  PMID: 20413901 BACKGROUND

• Corbett A, Owen A, Hampshire A, Grahn J, Stenton R, Dajani S, Burns A, Howard R, Williams N, Williams G, Ballard C. The Effect of an Online Cognitive Training Package in Healthy Older Adults: An Online Randomized Controlled Trial. J Am Med Dir Assoc. 2015 Nov 1;16(11):990-7. doi: 10.1016/j.jamda.2015.06.014.

  PMID: 26543007 BACKGROUND

• Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

  PMID: 7991117 BACKGROUND

• Elliott C, Rojo AI, Ribe E, Broadstock M, Xia W, Morin P, Semenov M, Baillie G, Cuadrado A, Al-Shawi R, Ballard CG, Simons P, Killick R. A role for APP in Wnt signalling links synapse loss with beta-amyloid production. Transl Psychiatry. 2018 Sep 20;8(1):179. doi: 10.1038/s41398-018-0231-6.

  PMID: 30232325 BACKGROUND

• Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351.

  PMID: 3496763 BACKGROUND

• Fukumoto Y, Yamada N, Matsubara H, Mizoguchi M, Uchino K, Yao A, Kihara Y, Kawano M, Watanabe H, Takeda Y, Adachi T, Osanai S, Tanabe N, Inoue T, Kubo A, Ota Y, Fukuda K, Nakano T, Shimokawa H. Double-blind, placebo-controlled clinical trial with a rho-kinase inhibitor in pulmonary arterial hypertension. Circ J. 2013;77(10):2619-25. doi: 10.1253/circj.cj-13-0443. Epub 2013 Aug 3.

  PMID: 23912836 BACKGROUND

• Herholz K, Salmon E, Perani D, Baron JC, Holthoff V, Frolich L, Schonknecht P, Ito K, Mielke R, Kalbe E, Zundorf G, Delbeuck X, Pelati O, Anchisi D, Fazio F, Kerrouche N, Desgranges B, Eustache F, Beuthien-Baumann B, Menzel C, Schroder J, Kato T, Arahata Y, Henze M, Heiss WD. Discrimination between Alzheimer dementia and controls by automated analysis of multicenter FDG PET. Neuroimage. 2002 Sep;17(1):302-16. doi: 10.1006/nimg.2002.1208.

  PMID: 12482085 BACKGROUND

• Hinderling PH, Karara AH, Tao B, Pawula M, Wilding I, Lu M. Systemic availability of the active metabolite hydroxy-fasudil after administration of fasudil to different sites of the human gastrointestinal tract. J Clin Pharmacol. 2007 Jan;47(1):19-25. doi: 10.1177/0091270006293767.

  PMID: 17192498 BACKGROUND

• Ido K, Kurogi R, Kurogi A, Nishimura K, Arimura K, Nishimura A, Ren N, Kada A, Matsuo R, Onozuka D, Hagihara A, Takagishi S, Yamagami K, Takegami M, Nohara Y, Nakashima N, Kamouchi M, Date I, Kitazono T, Iihara K; J-ASPECT Study Collaborators. Effect of treatment modality and cerebral vasospasm agent on patient outcomes after aneurysmal subarachnoid hemorrhage in the elderly aged 75 years and older. PLoS One. 2020 Apr 9;15(4):e0230953. doi: 10.1371/journal.pone.0230953. eCollection 2020.

  PMID: 32271814 BACKGROUND

• Gillett R. Assessment of working memory performance in self-ordered selection tests. Cortex. 2007 Nov;43(8):1047-56. doi: 10.1016/s0010-9452(08)70702-0.

  PMID: 18044665 BACKGROUND

• Grill JD, Di L, Lu PH, Lee C, Ringman J, Apostolova LG, Chow N, Kohannim O, Cummings JL, Thompson PM, Elashoff D; Alzheimer's Disease Neuroimaging Initiative. Estimating sample sizes for predementia Alzheimer's trials based on the Alzheimer's Disease Neuroimaging Initiative. Neurobiol Aging. 2013 Jan;34(1):62-72. doi: 10.1016/j.neurobiolaging.2012.03.006. Epub 2012 Apr 13.

  PMID: 22503160 BACKGROUND

• Huentelman MJ, Stephan DA, Talboom J, Corneveaux JJ, Reiman DM, Gerber JD, Barnes CA, Alexander GE, Reiman EM, Bimonte-Nelson HA. Peripheral delivery of a ROCK inhibitor improves learning and working memory. Behav Neurosci. 2009 Feb;123(1):218-23. doi: 10.1037/a0014260.

  PMID: 19170447 BACKGROUND

• Huntley J, Corbett A, Wesnes K, Brooker H, Stenton R, Hampshire A, Ballard C. Online assessment of risk factors for dementia and cognitive function in healthy adults. Int J Geriatr Psychiatry. 2018 Feb;33(2):e286-e293. doi: 10.1002/gps.4790. Epub 2017 Sep 27.

  PMID: 28960500 BACKGROUND

• Ismail Z, Smith EE, Geda Y, Sultzer D, Brodaty H, Smith G, Aguera-Ortiz L, Sweet R, Miller D, Lyketsos CG; ISTAART Neuropsychiatric Symptoms Professional Interest Area. Neuropsychiatric symptoms as early manifestations of emergent dementia: Provisional diagnostic criteria for mild behavioral impairment. Alzheimers Dement. 2016 Feb;12(2):195-202. doi: 10.1016/j.jalz.2015.05.017. Epub 2015 Jun 18.

  PMID: 26096665 BACKGROUND

• Janelidze S, Palmqvist S, Leuzy A, Stomrud E, Verberk IMW, Zetterberg H, Ashton NJ, Pesini P, Sarasa L, Allue JA, Teunissen CE, Dage JL, Blennow K, Mattsson-Carlgren N, Hansson O. Detecting amyloid positivity in early Alzheimer's disease using combinations of plasma Abeta42/Abeta40 and p-tau. Alzheimers Dement. 2022 Feb;18(2):283-293. doi: 10.1002/alz.12395. Epub 2021 Jun 20.

  PMID: 34151519 BACKGROUND

• Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.

  PMID: 11001602 BACKGROUND

• Kamei S, Oishi M, Takasu T. Evaluation of fasudil hydrochloride treatment for wandering symptoms in cerebrovascular dementia with 31P-magnetic resonance spectroscopy and Xe-computed tomography. Clin Neuropharmacol. 1996 Oct;19(5):428-38. doi: 10.1097/00002826-199619050-00006.

  PMID: 8889286 BACKGROUND

• Killick R, Ribe EM, Al-Shawi R, Malik B, Hooper C, Fernandes C, Dobson R, Nolan PM, Lourdusamy A, Furney S, Lin K, Breen G, Wroe R, To AW, Leroy K, Causevic M, Usardi A, Robinson M, Noble W, Williamson R, Lunnon K, Kellie S, Reynolds CH, Bazenet C, Hodges A, Brion JP, Stephenson J, Simons JP, Lovestone S. Clusterin regulates beta-amyloid toxicity via Dickkopf-1-driven induction of the wnt-PCP-JNK pathway. Mol Psychiatry. 2014 Jan;19(1):88-98. doi: 10.1038/mp.2012.163. Epub 2012 Nov 20.

  PMID: 23164821 BACKGROUND

• Koster N, Knol DL, Uitdehaag BM, Scheltens P, Sikkes SA. The sensitivity to change over time of the Amsterdam IADL Questionnaire((c)). Alzheimers Dement. 2015 Oct;11(10):1231-40. doi: 10.1016/j.jalz.2014.10.006. Epub 2015 Jan 15.

  PMID: 25598195 BACKGROUND

• Landau SM, Harvey D, Madison CM, Koeppe RA, Reiman EM, Foster NL, Weiner MW, Jagust WJ; Alzheimer's Disease Neuroimaging Initiative. Associations between cognitive, functional, and FDG-PET measures of decline in AD and MCI. Neurobiol Aging. 2011 Jul;32(7):1207-18. doi: 10.1016/j.neurobiolaging.2009.07.002. Epub 2009 Aug 5.

  PMID: 19660834 BACKGROUND

• Morbelli S, Brugnolo A, Bossert I, Buschiazzo A, Frisoni GB, Galluzzi S, van Berckel BN, Ossenkoppele R, Perneczky R, Drzezga A, Didic M, Guedj E, Sambuceti G, Bottoni G, Arnaldi D, Picco A, De Carli F, Pagani M, Nobili F. Visual versus semi-quantitative analysis of 18F-FDG-PET in amnestic MCI: an European Alzheimer's Disease Consortium (EADC) project. J Alzheimers Dis. 2015;44(3):815-26. doi: 10.3233/JAD-142229.

  PMID: 25362041 BACKGROUND

• Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.

  PMID: 8232972 BACKGROUND

• Nair AB, Jacob S. A simple practice guide for dose conversion between animals and human. J Basic Clin Pharm. 2016 Mar;7(2):27-31. doi: 10.4103/0976-0105.177703.

  PMID: 27057123 BACKGROUND

• Reijs BL, Teunissen CE, Goncharenko N, Betsou F, Blennow K, Baldeiras I, Brosseron F, Cavedo E, Fladby T, Froelich L, Gabryelewicz T, Gurvit H, Kapaki E, Koson P, Kulic L, Lehmann S, Lewczuk P, Lleo A, Maetzler W, de Mendonca A, Miller AM, Molinuevo JL, Mollenhauer B, Parnetti L, Rot U, Schneider A, Simonsen AH, Tagliavini F, Tsolaki M, Verbeek MM, Verhey FR, Zboch M, Winblad B, Scheltens P, Zetterberg H, Visser PJ. The Central Biobank and Virtual Biobank of BIOMARKAPD: A Resource for Studies on Neurodegenerative Diseases. Front Neurol. 2015 Oct 15;6:216. doi: 10.3389/fneur.2015.00216. eCollection 2015.

  PMID: 26528237 BACKGROUND

• Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.

  PMID: 6496779 BACKGROUND

• Schneider LS, Olin JT, Doody RS, Clark CM, Morris JC, Reisberg B, Schmitt FA, Grundman M, Thomas RG, Ferris SH. Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S22-32. doi: 10.1097/00002093-199700112-00004.

  PMID: 9236949 BACKGROUND

• Sellers KJ, Elliott C, Jackson J, Ghosh A, Ribe E, Rojo AI, Jarosz-Griffiths HH, Watson IA, Xia W, Semenov M, Morin P, Hooper NM, Porter R, Preston J, Al-Shawi R, Baillie G, Lovestone S, Cuadrado A, Harte M, Simons P, Srivastava DP, Killick R. Amyloid beta synaptotoxicity is Wnt-PCP dependent and blocked by fasudil. Alzheimers Dement. 2018 Mar;14(3):306-317. doi: 10.1016/j.jalz.2017.09.008. Epub 2017 Oct 19.

  PMID: 29055813 BACKGROUND

• Smith SC, Lamping DL, Banerjee S, Harwood RH, Foley B, Smith P, Cook JC, Murray J, Prince M, Levin E, Mann A, Knapp M. Development of a new measure of health-related quality of life for people with dementia: DEMQOL. Psychol Med. 2007 May;37(5):737-46. doi: 10.1017/S0033291706009469. Epub 2006 Dec 19.

  PMID: 17176501 BACKGROUND

• Song Y, Chen X, Wang LY, Gao W, Zhu MJ. Rho kinase inhibitor fasudil protects against beta-amyloid-induced hippocampal neurodegeneration in rats. CNS Neurosci Ther. 2013 Aug;19(8):603-10. doi: 10.1111/cns.12116. Epub 2013 May 3.

  PMID: 23638992 BACKGROUND

• Suzuki Y, Shibuya M, Satoh S, Sugiyama H, Seto M, Takakura K. Safety and efficacy of fasudil monotherapy and fasudil-ozagrel combination therapy in patients with subarachnoid hemorrhage: sub-analysis of the post-marketing surveillance study. Neurol Med Chir (Tokyo). 2008 Jun;48(6):241-7; discussion 247-8. doi: 10.2176/nmc.48.241.

  PMID: 18574328 BACKGROUND

• Tanaka K, Minami H, Kota M, Kuwamura K, Kohmura E. Treatment of cerebral vasospasm with intra-arterial fasudil hydrochloride. Neurosurgery. 2005 Feb;56(2):214-23; discussion 214-23. doi: 10.1227/01.neu.0000147975.24556.bc.

  PMID: 15670369 BACKGROUND

• van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.

  PMID: 36449413 BACKGROUND

• Wesnes KA, Brooker H, Ballard C, McCambridge L, Stenton R, Corbett A. Utility, reliability, sensitivity and validity of an online test system designed to monitor changes in cognitive function in clinical trials. Int J Geriatr Psychiatry. 2017 Dec;32(12):e83-e92. doi: 10.1002/gps.4659. Epub 2017 Jan 27.

  PMID: 28128869 BACKGROUND

• Williams MM, Storandt M, Roe CM, Morris JC. Progression of Alzheimer's disease as measured by Clinical Dementia Rating Sum of Boxes scores. Alzheimers Dement. 2013 Feb;9(1 Suppl):S39-44. doi: 10.1016/j.jalz.2012.01.005. Epub 2012 Aug 1.

  PMID: 22858530 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Lymphoma, Follicular; Alzheimer Disease

Interventions

fasudil

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Central Study Contacts

Dag Aarsland, PhD

CONTACT

+4797575804; daarsland@gmail.com

Nicolas Castellanos Perilla, MD

CONTACT

+4741279857; nicolascastellanos1107@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: April 12, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (6)