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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 05398naa a2200877 4500 | |
| 001 | oai:gup.ub.gu.se/212870 | |
| 003 | SwePub | |
| 008 | 240528s2014 | |||||||||||000 ||eng| | |
| 024 | 7 | a https://gup.ub.gu.se/publication/2128702 URI |
| 024 | 7 | a https://doi.org/10.1136/bmjopen-2014-0063642 DOI |
| 040 | a (SwePub)gu | |
| 041 | a eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a Lawlor, B.4 aut |
| 245 | 1 0 | a NILVAD protocol: A European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease |
| 264 | c 2014-10-09 | |
| 264 | 1 | b BMJ Publishing Group,c 2014 |
| 520 | a Introduction: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82 weeks with a treatment period of 78 weeks. Methods and analysis: Adult patients, males and females over 50 years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's disease and Related Disorders Association (NINCDSADRDA) criteria, will be included in the study. It aims to recruit a total of 500 patients with AD; 250 in the nilvadipine group and 250 in the placebo group. Participants will be randomised to receive nilvadipine, an 8 mg overencapsulated, sustained release capsule, or a matching overencapsulated placebo (sugar pill) for a period of 78 weeks of treatment. The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer's disease Assessment Scale (ADASCog 12) from baseline to the end of treatment duration (78 weeks). There are two key secondary outcome measures, the Clinical Dementia Rating Scale Sum of Boxes (CDRsb) and the Disability Assessment for Dementia (DAD). If a statistically significant effect is seen in the primary outcome, CDRsb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis. Ethics and dissemination: The study and all subsequent amendments have received ethical approval within each participating country according to national regulations. Each participant will provide written consent to participate in the study. All participants will remain anonymised throughout and the results of the study will be published in an international peerreviewed journal. Trial registration number EUDRACT Reference Number: 201200276427. | |
| 650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Neurovetenskaper0 (SwePub)301052 hsv//swe |
| 650 | 7 | a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Neurosciences0 (SwePub)301052 hsv//eng |
| 653 | a nilvadipine | |
| 653 | a placebo | |
| 653 | a adult | |
| 653 | a Alzheimer disease | |
| 653 | a Alzheimer Disease Assessment Scale | |
| 653 | a Article | |
| 653 | a Clinical Dementia Rating | |
| 653 | a cognition | |
| 653 | a controlled study | |
| 653 | a Disability Assessment for Dementia | |
| 653 | a disease course | |
| 653 | a drug efficacy | |
| 653 | a drug safety | |
| 653 | a female | |
| 653 | a human | |
| 653 | a major clinical study | |
| 653 | a male | |
| 653 | a multicenter study (topic) | |
| 653 | a named inventories | |
| 653 | a questionnaires and rating scales | |
| 653 | a phase 3 clinical trial (topic) | |
| 653 | a randomized controlled trial (topic) | |
| 653 | a sustained release preparation | |
| 653 | a treatment duration | |
| 700 | 1 | a Kennelly, S.4 aut |
| 700 | 1 | a O'Dwyer, S.4 aut |
| 700 | 1 | a Cregg, F.4 aut |
| 700 | 1 | a Walsh, C.4 aut |
| 700 | 1 | a Coen, R.4 aut |
| 700 | 1 | a Kenny, R. A.4 aut |
| 700 | 1 | a Howard, R.4 aut |
| 700 | 1 | a Murphy, C.4 aut |
| 700 | 1 | a Adams, J.4 aut |
| 700 | 1 | a Daly, L.4 aut |
| 700 | 1 | a Segurado, R.4 aut |
| 700 | 1 | a Gaynor, S.4 aut |
| 700 | 1 | a Crawford, F.4 aut |
| 700 | 1 | a Mullan, M.4 aut |
| 700 | 1 | a Lucca, U.4 aut |
| 700 | 1 | a Banzi, R.4 aut |
| 700 | 1 | a Pasquier, F.4 aut |
| 700 | 1 | a Breuilh, L.4 aut |
| 700 | 1 | a Riepe, M.4 aut |
| 700 | 1 | a Kalman, J.4 aut |
| 700 | 1 | a Wallin, Anders,d 1950u Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry4 aut0 (Swepub:gu)xwaand |
| 700 | 1 | a Börjesson-Hanson, Anne,d 1959u Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry4 aut0 (Swepub:gu)xborja |
| 700 | 1 | a Molloy, W.4 aut |
| 700 | 1 | a Tsolaki, M.4 aut |
| 700 | 1 | a Olde Rikkert, M.4 aut |
| 710 | 2 | a Göteborgs universitetb Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi4 org |
| 773 | 0 | t BMJ Opend : BMJ Publishing Groupg 4:10q 4:10x 2044-6055 |
| 856 | 4 | u https://doi.org/10.1136/bmjopen-2014-006364 |
| 856 | 4 8 | u https://gup.ub.gu.se/publication/212870 |
| 856 | 4 8 | u https://doi.org/10.1136/bmjopen-2014-006364 |
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