A Phase III Trial of Nilvadipine to Treat Alzheimer's Disease
NCT ID: NCT02017340
Last Updated: 2017-03-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
511 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-04-24
Study Completion Date
2016-12-16
Brief Summary
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Alzheimer's disease (AD) is an ever-increasing public health concern among the aging population and is the most common form of dementia affecting more than 15 million individuals worldwide and around 5 million Europeans. The direct and indirect costs of AD and other dementias amount to more than €440,000 million each year (www.alz.org, 2010).
Even modest therapeutic advances that delay disease onset and progression could significantly reduce the global burden of the disease and the level of care required by patients. While there are symptomatic-based drug therapies available for AD, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments for AD that have disease modifying effects. This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical studies with this medication have shown stabilization of cognitive decline and reduced incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities and frailty will be included in the study. If this trial is successful, nilvadipine would represent an advance in the treatment of AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe.
Even modest therapeutic advances that delay disease onset and progression could significantly reduce the global burden of the disease and the level of care required by patients. While there are symptomatic-based drug therapies available for AD, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments for AD that have disease modifying effects. This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical studies with this medication have shown stabilization of cognitive decline and reduced incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities and frailty will be included in the study. If this trial is successful, nilvadipine would represent an advance in the treatment of AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe.
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Detailed Description
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Please see 'Brief Summary', above
Conditions
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Alzheimer's Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Placebo
250 patients will receive the placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
8mg Placebo tablet taken once a day at lunch time for 78 weeks
Nilvadipine
250 patient will receive the active drug Nilvadipine 8mg
Group Type
ACTIVE_COMPARATOR
Nilvadipine
Intervention Type
DRUG
8mg of Nilvadipine taken once a day at lunch time for 78 weeks
Interventions
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Nilvadipine
8mg of Nilvadipine taken once a day at lunch time for 78 weeks
Intervention Type
DRUG
Placebo
8mg Placebo tablet taken once a day at lunch time for 78 weeks
Intervention Type
DRUG
Other Intervention Names
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Also known as Nilvadil (Brand Name)
Eligibility Criteria
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Inclusion Criteria
1. Age range: Adult subjects, males and females over age 50 years.
2. Prior diagnosis of mild to moderate probable AD based on NINCDS-ADRDA criteria (see Appendix B) and
3. Standardised Mini-Mental State Examination (SMMSE) score \> 12 on stable dose (\>3 months of cholinesterase inhibitor and or memantine). Subjects who are not on cholinesterase inhibitors or memantine due to poor tolerability and/or who will not require treatment with these medications during the course of the study can be included.
4. Collateral informants such as a spouse, family member, close friend. The informant must have close contact with the subject and agree to monitor/manage study drug adherence, observe for possible adverse events, assist with psychometric measures requiring informant information, and accompany the subject to all evaluation visits.
5. Fluency in relevant language sufficient to reliably complete all study assessments.
6. Systolic BP \> 100 mmHg but ≤ 159 mmHg, and diastolic BP \> 65 mmHg but ≤ 99 mmHg on resting office based BP measurements, or a Systolic BP \> 105 mmHg but ≤ 140 mmHg, and diastolic BP \> 70 mmHg but ≤ 90 mmHg on ABPM measurement
2. Prior diagnosis of mild to moderate probable AD based on NINCDS-ADRDA criteria (see Appendix B) and
3. Standardised Mini-Mental State Examination (SMMSE) score \> 12 on stable dose (\>3 months of cholinesterase inhibitor and or memantine). Subjects who are not on cholinesterase inhibitors or memantine due to poor tolerability and/or who will not require treatment with these medications during the course of the study can be included.
4. Collateral informants such as a spouse, family member, close friend. The informant must have close contact with the subject and agree to monitor/manage study drug adherence, observe for possible adverse events, assist with psychometric measures requiring informant information, and accompany the subject to all evaluation visits.
5. Fluency in relevant language sufficient to reliably complete all study assessments.
6. Systolic BP \> 100 mmHg but ≤ 159 mmHg, and diastolic BP \> 65 mmHg but ≤ 99 mmHg on resting office based BP measurements, or a Systolic BP \> 105 mmHg but ≤ 140 mmHg, and diastolic BP \> 70 mmHg but ≤ 90 mmHg on ABPM measurement
Exclusion Criteria
1. Subjects with co-morbid dementia due to other neurological disorders such as Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Creutzfeldt-Jakob disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis, as well as subjects with HIV disease, neurosyphilis, history of significant head trauma with loss of consciousness followed by persistent neurological deficits, known structural brain abnormalities, or any other condition known to interfere with cognitive function.
2. Subjects currently taking any calcium channel blocker or Beta-blocker
3. Subjects who in the opinion of the investigator, have a medical condition that would preclude them from participating in the study (e.g.hemodynamically significant coronary artery disease., chronic heart failure, syncope within the past year, significant valvular heart disease i.e. severe aortic and mitral stenosis.. symptomatic orthostatic hypotension within the last year, subjects requiring more than one agent to control BP.), or subjects who in the opinion of the investigator are unlikely to complete per protocol due to care issues etc:
4. Current Axis I diagnosis of schizophrenia, bipolar disorder, major depression. Subjects who are currently or who have within the past year met criteria for drug or alcohol abuse or dependence.
5. Pregnant women or women who may possibly become pregnant.
6. Subjects with a history of hypersensitivity to nilvadipine (Nivadil).
7. Subjects who have taken an investigational or other unapproved drug during the 30 days or five half-lives, whichever is longer, prior to baseline.
8. Subjects who are participating in other research studies.
9. Patients with a SBP of ≤ 100 mmHg and/or a DBP of ≤ 65 mmHg on office based BP measurements, or a SBP ≤ 105 mmHg and/or a DBP of ≤ 70 mmHg on ABPM will not be included in the study.
2. Subjects currently taking any calcium channel blocker or Beta-blocker
3. Subjects who in the opinion of the investigator, have a medical condition that would preclude them from participating in the study (e.g.hemodynamically significant coronary artery disease., chronic heart failure, syncope within the past year, significant valvular heart disease i.e. severe aortic and mitral stenosis.. symptomatic orthostatic hypotension within the last year, subjects requiring more than one agent to control BP.), or subjects who in the opinion of the investigator are unlikely to complete per protocol due to care issues etc:
4. Current Axis I diagnosis of schizophrenia, bipolar disorder, major depression. Subjects who are currently or who have within the past year met criteria for drug or alcohol abuse or dependence.
5. Pregnant women or women who may possibly become pregnant.
6. Subjects with a history of hypersensitivity to nilvadipine (Nivadil).
7. Subjects who have taken an investigational or other unapproved drug during the 30 days or five half-lives, whichever is longer, prior to baseline.
8. Subjects who are participating in other research studies.
9. Patients with a SBP of ≤ 100 mmHg and/or a DBP of ≤ 65 mmHg on office based BP measurements, or a SBP ≤ 105 mmHg and/or a DBP of ≤ 70 mmHg on ABPM will not be included in the study.
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Dublin, Trinity College
OTHER
Sponsor Role
collaborator
Molecular Medicine Ireland LBG
UNKNOWN
Sponsor Role
collaborator
Alzheimer Europe
OTHER
Sponsor Role
collaborator
Archer Pharmaceuticals, Inc.
INDUSTRY
Sponsor Role
collaborator
E-Search Limited
UNKNOWN
Sponsor Role
collaborator
University College Dublin
OTHER
Sponsor Role
collaborator
King's College London
OTHER
Sponsor Role
collaborator
Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
Sponsor Role
collaborator
University Hospital, Lille
OTHER
Sponsor Role
collaborator
University of Ulm
OTHER
Sponsor Role
collaborator
Szeged University
OTHER
Sponsor Role
collaborator
Göteborg University
OTHER
Sponsor Role
collaborator
University College Cork
OTHER
Sponsor Role
collaborator
Aristotle University Of Thessaloniki
OTHER
Sponsor Role
collaborator
Stichting Katholieke Universiteit
OTHER
Sponsor Role
collaborator
Prof Brian Lawlor
OTHER
Sponsor Role
lead
Responsible Party
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Prof Brian Lawlor
Project Coordinator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Brian Lawlor, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Dublin, Trinity College
Locations
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Centre Hospitalier Universitaire d'Amiens (CHU Amiens)
Amiens, , France
Site Status
Centre Hospitalier Universitaire de Bethune (CH Bethune)
Béthune, , France
Site Status
Centre Hospitalier Universitaire de Caen (CHU Caen)
Caen, , France
Site Status
Centre Hospitalier Universitaire de Calais (CHU Calais)
Calais, , France
Site Status
Centre Hospitalier Universitaire de Lens (CHU Lens)
Lens, , France
Site Status
Centre Hospitalier Regional et Universitaire de Lille (CHRU Lille)
Lille, , France
Site Status
Centre Hospitalier Universitaire de Saint Philibert (GHICL)
Lille, , France
Site Status
University of Ulm
Ulm, , Germany
Site Status
"G. Papanicolaou" Hospital
Athens, , Greece
Site Status
"G.Papageorgiou" Hospital
Athens, , Greece
Site Status
AXEPA Hospital
Athens, , Greece
Site Status
Szeged University
Szeged, , Hungary
Site Status
University College Cork
Cork, , Ireland
Site Status
St James Hospital
Dublin, , Ireland
Site Status
Hospital of Brescia
Brescia, , Italy
Site Status
Hospital Castellanza
Castellanza, , Italy
Site Status
Hospital of Genoa
Genoa, , Italy
Site Status
Hospital of Milan
Milan, , Italy
Site Status
Hospital of Arnhem
Arnhem, , Netherlands
Site Status
Hospital of Maastricht
Maastricht, , Netherlands
Site Status
Hospital of Nijmegen
Nijmegen, , Netherlands
Site Status
Gothenburg Univeristy
Gothenburg, , Sweden
Site Status
Kings College London
London, , United Kingdom
Site Status
Countries
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France
Germany
Greece
Hungary
Ireland
Italy
Netherlands
Sweden
United Kingdom
References
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Brogden RN, McTavish D. Nilvadipine. A review of its pharmacodynamic and pharmacokinetic properties, therapeutic use in hypertension and potential in cerebrovascular disease and angina. Drugs Aging. 1995 Feb;6(2):150-71. doi: 10.2165/00002512-199506020-00007.
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Forette F, Seux ML, Staessen JA, Thijs L, Babarskiene MR, Babeanu S, Bossini A, Fagard R, Gil-Extremera B, Laks T, Kobalava Z, Sarti C, Tuomilehto J, Vanhanen H, Webster J, Yodfat Y, Birkenhager WH; Systolic Hypertension in Europe Investigators. The prevention of dementia with antihypertensive treatment: new evidence from the Systolic Hypertension in Europe (Syst-Eur) study. Arch Intern Med. 2002 Oct 14;162(18):2046-52. doi: 10.1001/archinte.162.18.2046.
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Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
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Furuichi Y, Takakura S, Satoh H, Mori J, Kohsaka M. The effect of nilvadipine, a dihydropyridine type calcium channel blocker, on local cerebral blood flow in rats. Jpn J Pharmacol. 1992 Apr;58(4):457-60. doi: 10.1254/jjp.58.457.
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Gelinas I, Gauthier L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther. 1999 Sep-Oct;53(5):471-81. doi: 10.5014/ajot.53.5.471.
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Hanyu H, Hirao K, Shimizu S, Sato T, Kiuchi A, Iwamoto T. Nilvadipine prevents cognitive decline of patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2007 Dec;22(12):1264-6. doi: 10.1002/gps.1851. No abstract available.
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Inouye M, Mio T, Sumino K. Nilvadipine protects low-density lipoprotein cholesterol from in vivo oxidation in hypertensive patients with risk factors for atherosclerosis. Eur J Clin Pharmacol. 2000 Apr;56(1):35-41. doi: 10.1007/s002280050717.
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Khachaturian AS, Zandi PP, Lyketsos CG, Hayden KM, Skoog I, Norton MC, Tschanz JT, Mayer LS, Welsh-Bohmer KA, Breitner JC. Antihypertensive medication use and incident Alzheimer disease: the Cache County Study. Arch Neurol. 2006 May;63(5):686-92. doi: 10.1001/archneur.63.5.noc60013. Epub 2006 Mar 13.
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Kagawa H, Nomura S, Ozaki Y, Nagahama M, Fukuhara S. Effects of nilvadipine on cytokine-levels and soluble factors in collagen disease complicated with essential hypertension. Clin Exp Hypertens. 1999 Oct;21(7):1177-88. doi: 10.3109/10641969909052196.
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Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.
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Maxwell CJ, Hogan DB, Ebly EM. Calcium-channel blockers and cognitive function in elderly people: results from the Canadian Study of Health and Aging. CMAJ. 1999 Sep 7;161(5):501-6.
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McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
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Mohs RC, Rosen WG, Davis KL. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull. 1983;19(3):448-50. No abstract available.
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Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.
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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.
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Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
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Ogasawara K, Noda A, Yasuda S, Kobayashi M, Yukawa H, Ogawa A. Effect of calcium antagonist on cerebral blood flow and oxygen metabolism in patients with hypertension and chronic major cerebral artery occlusion: a positron emission tomography study. Nucl Med Commun. 2003 Jan;24(1):71-6. doi: 10.1097/00006231-200301000-00017.
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Ohtsuka M, Ono T, Hiroi J, Esumi K, Kikuchi H, Kumada S. Comparison of the cardiovascular effect of FR34235, a new dihydropyridine, with other calcium antagonists. J Cardiovasc Pharmacol. 1983 Nov-Dec;5(6):1074-82. doi: 10.1097/00005344-198311000-00024.
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Parry SW, Steen N, Baptist M, Fiaschi KA, Parry O, Kenny RA. Cerebral autoregulation is impaired in cardioinhibitory carotid sinus syndrome. Heart. 2006 Jun;92(6):792-7. doi: 10.1136/hrt.2004.053348. Epub 2006 Jan 31.
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Rosenthal J. Nilvadipine: profile of a new calcium antagonist. An overview. J Cardiovasc Pharmacol. 1994;24 Suppl 2:S92-107.
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Shimamoto H, Shimamoto Y. Nilvadipine increases cerebral blood flow in elderly hypertensives: comparison with nifedipine. J Hum Hypertens. 1995 Apr;9(4):271-9.
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Tollefson GD. Short-term effects of the calcium channel blocker nimodipine (Bay-e-9736) in the management of primary degenerative dementia. Biol Psychiatry. 1990 May 15;27(10):1133-42. doi: 10.1016/0006-3223(90)90050-c.
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Verghese J, Lipton RB, Katz MJ, Hall CB, Derby CA, Kuslansky G, Ambrose AF, Sliwinski M, Buschke H. Leisure activities and the risk of dementia in the elderly. N Engl J Med. 2003 Jun 19;348(25):2508-16. doi: 10.1056/NEJMoa022252.
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Yasar S, Corrada M, Brookmeyer R, Kawas C. Calcium channel blockers and risk of AD: the Baltimore Longitudinal Study of Aging. Neurobiol Aging. 2005 Feb;26(2):157-63. doi: 10.1016/j.neurobiolaging.2004.03.009.
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BACKGROUND
Dyer AH, Lawlor B, Kennelly SP; NILVAD Study Group. Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD. BMC Geriatr. 2020 Mar 30;20(1):117. doi: 10.1186/s12877-020-01531-w.
Reference Type
DERIVED
Abdullah L, Crawford F, Tsolaki M, Borjesson-Hanson A, Olde Rikkert M, Pasquier F, Wallin A, Kennelly S, Ait-Ghezala G, Paris D, Hendrix S, Blennow K, Lawlor B, Mullan M. The Influence of Baseline Alzheimer's Disease Severity on Cognitive Decline and CSF Biomarkers in the NILVAD Trial. Front Neurol. 2020 Mar 6;11:149. doi: 10.3389/fneur.2020.00149. eCollection 2020.
Reference Type
DERIVED
de Heus RAA, Olde Rikkert MGM, Tully PJ, Lawlor BA, Claassen JAHR; NILVAD Study Group. Blood Pressure Variability and Progression of Clinical Alzheimer Disease. Hypertension. 2019 Nov;74(5):1172-1180. doi: 10.1161/HYPERTENSIONAHA.119.13664. Epub 2019 Sep 23.
Reference Type
DERIVED
de Jong DLK, de Heus RAA, Rijpma A, Donders R, Olde Rikkert MGM, Gunther M, Lawlor BA, van Osch MJP, Claassen JAHR. Effects of Nilvadipine on Cerebral Blood Flow in Patients With Alzheimer Disease. Hypertension. 2019 Aug;74(2):413-420. doi: 10.1161/HYPERTENSIONAHA.119.12892. Epub 2019 Jun 17.
Reference Type
DERIVED
de Heus RAA, Donders R, Santoso AMM, Olde Rikkert MGM, Lawlor BA, Claassen JAHR; Nilvad Study Group. Blood Pressure Lowering With Nilvadipine in Patients With Mild-to-Moderate Alzheimer Disease Does Not Increase the Prevalence of Orthostatic Hypotension. J Am Heart Assoc. 2019 May 21;8(10):e011938. doi: 10.1161/JAHA.119.011938.
Reference Type
DERIVED
Lawlor B, Segurado R, Kennelly S, Olde Rikkert MGM, Howard R, Pasquier F, Borjesson-Hanson A, Tsolaki M, Lucca U, Molloy DW, Coen R, Riepe MW, Kalman J, Kenny RA, Cregg F, O'Dwyer S, Walsh C, Adams J, Banzi R, Breuilh L, Daly L, Hendrix S, Aisen P, Gaynor S, Sheikhi A, Taekema DG, Verhey FR, Nemni R, Nobili F, Franceschi M, Frisoni G, Zanetti O, Konsta A, Anastasios O, Nenopoulou S, Tsolaki-Tagaraki F, Pakaski M, Dereeper O, de la Sayette V, Senechal O, Lavenu I, Devendeville A, Calais G, Crawford F, Mullan M; NILVAD Study Group. Nilvadipine in mild to moderate Alzheimer disease: A randomised controlled trial. PLoS Med. 2018 Sep 24;15(9):e1002660. doi: 10.1371/journal.pmed.1002660. eCollection 2018 Sep.
Reference Type
DERIVED
Other Identifiers
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2012-002764-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
279093
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NILVAD2012
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
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COMPLETED
PHASE1
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PHASE2
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ACTIVE_NOT_RECRUITING
PHASE2
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UNKNOWN
PHASE3
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COMPLETED
PHASE1
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COMPLETED
PHASE2
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COMPLETED
PHASE1