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  1. Article: The Parkinson Progression Marker Initiative (PPMI)

    Marek, Kenneth / Jennings, Danna / Lasch, Shirley / Siderowf, Andrew / Tanner, Caroline / Simuni, Tanya / Coffey, Chris / Kieburtz, Karl / Flagg, Emily / Chowdhury, Sohini / Poewe, Werner / Mollenhauer, Brit / Klinik, Paracelsus-Elena / Sherer, Todd / Frasier, Mark / Meunier, Claire / Rudolph, Alice / Casaceli, Cindy / Seibyl, John /
    Mendick, Susan / Schuff, Norbert / Zhang, Ying / Toga, Arthur / Crawford, Karen / Ansbach, Alison / De Blasio, Pasquale / Piovella, Michele / Trojanowski, John / Shaw, Les / Singleton, Andrew / Hawkins, Keith / Eberling, Jamie / Brooks, Deborah / Russell, David / Leary, Laura / Factor, Stewart / Sommerfeld, Barbara / Hogarth, Penelope / Pighetti, Emily / Williams, Karen / Standaert, David / Guthrie, Stephanie / Hauser, Robert / Delgado, Holly / Jankovic, Joseph / Hunter, Christine / Stern, Matthew / Tran, Baochan / Leverenz, Jim / Baca, Marne / Frank, Sam / Thomas, Cathi-Ann / Richard, Irene / Deeley, Cheryl / Rees, Linda / Sprenger, Fabienne / Lang, Elisabeth / Shill, Holly / Obradov, Sanja / Fernandez, Hubert / Winters, Adrienna / Berg, Daniela / Gauss, Katharina / Galasko, Douglas / Fontaine, Deborah / Mari, Zoltan / Gerstenhaber, Melissa / Brooks, David / Malloy, Sophie / Barone, Paolo / Longo, Katia / Comery, Tom / Ravina, Bernard / Grachev, Igor / Gallagher, Kim / Collins, Michelle / Widnell, Katherine L / Ostrowizki, Suzanne / Fontoura, Paulo / Ho, Tony / Luthman, Johan / Brug, Marcel van der / Reith, Alastair D / Taylor, Peggy

    Progress in neurobiology. 2011 Dec., v. 95, no. 4

    2011  

    Abstract: The Parkinson Progression Marker Initiative (PPMI) is a comprehensive observational, international, multi-center study designed to identify PD progression biomarkers both to improve understanding of disease etiology and course and to provide crucial ... ...

    Institution The Parkinson Progression Marker Initiative
    Abstract The Parkinson Progression Marker Initiative (PPMI) is a comprehensive observational, international, multi-center study designed to identify PD progression biomarkers both to improve understanding of disease etiology and course and to provide crucial tools to enhance the likelihood of success of PD modifying therapeutic trials. The PPMI cohort will comprise 400 recently diagnosed PD and 200 healthy subjects followed longitudinally for clinical, imaging and biospecimen biomarker assessment using standardized data acquisition protocols at twenty-one clinical sites. All study data will be integrated in the PPMI study database and will be rapidly and publically available through the PPMI web site- www.ppmi-info.org. Biological samples including longitudinal collection of blood, cerebrospinal fluid (CSF) and urine will be available to scientists by application to an independent PPMI biospecimen review committee also through the PPMI web site. PPMI will rely on a partnership of government, PD foundations, industry and academics working cooperatively. This approach is crucial to enhance the potential for success of this ambitious strategy to develop PD progression biomarkers that will accelerate research in disease modifying therapeutics.
    Keywords biomarkers ; blood ; cerebrospinal fluid ; databases ; etiology ; image analysis ; industry ; scientists ; therapeutics ; urine
    Language English
    Dates of publication 2011-12
    Size p. 629-635.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 185535-9
    ISSN 1873-5118 ; 0301-0082
    ISSN (online) 1873-5118
    ISSN 0301-0082
    DOI 10.1016/j.pneurobio.2011.09.005
    Database NAL-Catalogue (AGRICOLA)

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  2. Article ; Online: A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit.

    Beal, M Flint / Oakes, David / Shoulson, Ira / Henchcliffe, Claire / Galpern, Wendy R / Haas, Richard / Juncos, Jorge L / Nutt, John G / Voss, Tiffini Smith / Ravina, Bernard / Shults, Clifford M / Helles, Karen / Snively, Victoria / Lew, Mark F / Griebner, Brian / Watts, Arthur / Gao, Shan / Pourcher, Emmanuelle / Bond, Louisette /
    Kompoliti, Katie / Agarwal, Pinky / Sia, Cherissa / Jog, Mandar / Cole, Linda / Sultana, Munira / Kurlan, Roger / Richard, Irene / Deeley, Cheryl / Waters, Cheryl H / Figueroa, Angel / Arkun, Ani / Brodsky, Matthew / Ondo, William G / Hunter, Christine B / Jimenez-Shahed, Joohi / Palao, Alicia / Miyasaki, Janis M / So, Julie / Tetrud, James / Reys, Liza / Smith, Katharine / Singer, Carlos / Blenke, Anita / Russell, David S / Cotto, Candace / Friedman, Joseph H / Lannon, Margaret / Zhang, Lin / Drasby, Edward / Kumar, Rajeev / Subramanian, Thyagarajan / Ford, Donna Stuppy / Grimes, David A / Cote, Diane / Conway, Jennifer / Siderowf, Andrew D / Evatt, Marian Leslie / Sommerfeld, Barbara / Lieberman, Abraham N / Okun, Michael S / Rodriguez, Ramon L / Merritt, Stacy / Swartz, Camille Louise / Martin, W R Wayne / King, Pamela / Stover, Natividad / Guthrie, Stephanie / Watts, Ray L / Ahmed, Anwar / Fernandez, Hubert H / Winters, Adrienna / Mari, Zoltan / Dawson, Ted M / Dunlop, Becky / Feigin, Andrew S / Shannon, Barbara / Nirenberg, Melissa Jill / Ogg, Mattson / Ellias, Samuel A / Thomas, Cathi-Ann / Frei, Karen / Bodis-Wollner, Ivan / Glazman, Sofya / Mayer, Thomas / Hauser, Robert A / Pahwa, Rajesh / Langhammer, April / Ranawaya, Ranjit / Derwent, Lorelei / Sethi, Kapil D / Farrow, Buff / Prakash, Rajan / Litvan, Irene / Robinson, Annette / Sahay, Alok / Gartner, Maureen / Hinson, Vanessa K / Markind, Samuel / Pelikan, Melisa / Perlmutter, Joel S / Hartlein, Johanna / Molho, Eric / Evans, Sharon / Adler, Charles H / Duffy, Amy / Lind, Marlene / Elmer, Lawrence / Davis, Kathy / Spears, Julia / Wilson, Stephanie / Leehey, Maureen A / Hermanowicz, Neal / Niswonger, Shari / Shill, Holly A / Obradov, Sanja / Rajput, Alex / Cowper, Marilyn / Lessig, Stephanie / Song, David / Fontaine, Deborah / Zadikoff, Cindy / Williams, Karen / Blindauer, Karen A / Bergholte, Jo / Propsom, Clara Schindler / Stacy, Mark A / Field, Joanne / Mihaila, Dragos / Chilton, Mark / Uc, Ergun Y / Sieren, Jeri / Simon, David K / Kraics, Lauren / Silver, Althea / Boyd, James T / Hamill, Robert W / Ingvoldstad, Christopher / Young, Jennifer / Thomas, Karen / Kostyk, Sandra K / Wojcieszek, Joanne / Pfeiffer, Ronald F / Panisset, Michel / Beland, Monica / Reich, Stephen G / Cines, Michelle / Zappala, Nancy / Rivest, Jean / Zweig, Richard / Lumina, L Pepper / Hilliard, Colette Lynn / Grill, Stephen / Kellermann, Marye / Tuite, Paul / Rolandelli, Susan / Kang, Un Jung / Young, Joan / Rao, Jayaraman / Cook, Maureen M / Severt, Lawrence / Boyar, Karyn

    JAMA neurology

    2014  Volume 71, Issue 5, Page(s) 543–552

    Abstract: Importance: Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A ... ...

    Abstract Importance: Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit.
    Objective: To examine whether CoQ10 could slow disease progression in early PD.
    Design, setting, and participants: A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson's Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation.
    Interventions: The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E.
    Main outcomes and measures: Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo.
    Results: The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants required treatment (94 received placebo, 87 received 1200 mg/d of CoQ10, and 86 received 2400 mg/d of CoQ10), and 65 participants (29 who received placebo, 19 who received 1200 mg/d of CoQ10, and 17 who received 2400 mg/d of CoQ10) withdrew prematurely. Treatments were well tolerated with no safety concerns. The study was terminated after a prespecified futility criterion was reached. At study termination, both active treatment groups showed slight adverse trends relative to placebo. Adjusted mean changes (worsening) in total UPDRS scores from baseline to final visit were 6.9 points (placebo), 7.5 points (1200 mg/d of CoQ10; P = .49 relative to placebo), and 8.0 points (2400 mg/d of CoQ10; P = .21 relative to placebo).
    Conclusions and relevance: Coenzyme Q10 was safe and well tolerated in this population, but showed no evidence of clinical benefit.
    Trial registration: clinicaltrials.gov Identifier: NCT00740714.
    MeSH term(s) Aged ; Antioxidants/administration & dosage ; Antioxidants/metabolism ; Dose-Response Relationship, Drug ; Double-Blind Method ; Early Diagnosis ; Female ; Humans ; Male ; Middle Aged ; Parkinson Disease/diagnosis ; Parkinson Disease/drug therapy ; Parkinson Disease/enzymology ; Prospective Studies ; Treatment Outcome ; Ubiquinone/administration & dosage ; Ubiquinone/analogs & derivatives ; Ubiquinone/blood
    Chemical Substances Antioxidants ; Ubiquinone (1339-63-5) ; coenzyme Q10 (EJ27X76M46)
    Language English
    Publishing date 2014-03-24
    Publishing country United States
    Document type Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2702023-X
    ISSN 2168-6157 ; 2168-6149
    ISSN (online) 2168-6157
    ISSN 2168-6149
    DOI 10.1001/jamaneurol.2014.131
    Database MEDical Literature Analysis and Retrieval System OnLINE

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