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  1. Article ; Online: Levodopa responsive freezing of gait is associated with reduced norepinephrine transporter binding in Parkinson's disease.

    McKay, J Lucas / Nye, Jonathan / Goldstein, Felicia C / Sommerfeld, Barbara / Smith, Yoland / Weinshenker, David / Factor, Stewart A

    Neurobiology of disease

    2023  Volume 179, Page(s) 106048

    Abstract: Background: Freezing of gait (FOG) is a major cause of falling in Parkinson's disease (PD) and can be responsive or unresponsive to levodopa. Pathophysiology is poorly understood.: Objective: To examine the link between noradrenergic systems, the ... ...

    Abstract Background: Freezing of gait (FOG) is a major cause of falling in Parkinson's disease (PD) and can be responsive or unresponsive to levodopa. Pathophysiology is poorly understood.
    Objective: To examine the link between noradrenergic systems, the development of FOG in PD and its responsiveness to levodopa.
    Methods: We examined norepinephrine transporter (NET) binding via brain positron emission tomography (PET) to evaluate changes in NET density associated with FOG using the high affinity selective NET antagonist radioligand [
    Results: Linear mixed models identified significant reductions in whole brain NET binding in the OFF-FOG group compared to the NO-FOG group (-16.8%, P = 0.021) and regionally in the frontal lobe, left and right thalamus, temporal lobe, and locus coeruleus, with the strongest effect in right thalamus (P = 0.038). Additional regions examined in a post hoc secondary analysis including the left and right amygdalae confirmed the contrast between OFF-FOG and NO-FOG (P = 0.003). A linear regression analysis identified an association between reduced NET binding in the right thalamus and more severe New FOG Questionnaire (N-FOG-Q) score only in the OFF-FOG group (P = 0.022).
    Conclusion: This is the first study to examine brain noradrenergic innervation using NET-PET in PD patients with and without FOG. Based on the normal regional distribution of noradrenergic innervation and pathological studies in the thalamus of PD patients, the implications of our findings suggest that noradrenergic limbic pathways may play a key role in OFF-FOG in PD. This finding could have implications for clinical subtyping of FOG as well as development of therapies.
    MeSH term(s) Humans ; Parkinson Disease/complications ; Parkinson Disease/diagnostic imaging ; Parkinson Disease/drug therapy ; Levodopa/therapeutic use ; Norepinephrine Plasma Membrane Transport Proteins ; Gait Disorders, Neurologic/diagnostic imaging ; Gait Disorders, Neurologic/drug therapy ; Gait Disorders, Neurologic/etiology ; Gait
    Chemical Substances Levodopa (46627O600J) ; Norepinephrine Plasma Membrane Transport Proteins
    Language English
    Publishing date 2023-02-21
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1211786-9
    ISSN 1095-953X ; 0969-9961
    ISSN (online) 1095-953X
    ISSN 0969-9961
    DOI 10.1016/j.nbd.2023.106048
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Freezing of Gait can persist after an acute levodopa challenge in Parkinson's disease.

    Lucas McKay, J / Goldstein, Felicia C / Sommerfeld, Barbara / Bernhard, Douglas / Perez Parra, Sahyli / Factor, Stewart A

    NPJ Parkinson's disease

    2019  Volume 5, Page(s) 25

    Abstract: Study objectives included testing whether presumed levodopa-unresponsive freezing of gait (FOG) in Parkinson's disease (PD) actually persists in the presence of adequate dopaminergic dosing and to investigate whether the presence of other parkinsonian ... ...

    Abstract Study objectives included testing whether presumed levodopa-unresponsive freezing of gait (FOG) in Parkinson's disease (PD) actually persists in the presence of adequate dopaminergic dosing and to investigate whether the presence of other parkinsonian features and their responsiveness to therapy varies across patients without FOG (NO-FOG), with levodopa-responsive FOG (OFF-FOG), and with levodopa-unresponsive FOG (ONOFF-FOG). Fifty-five PD patients completed levodopa challenges after >12-h OFF with supratherapeutic doses of dopaminergic medications. Observed responses in FOG, measured with MDS-UPDRS-III during the patient reported full "ON", were used to classify them as NO-FOG, OFF-FOG, or ONOFF-FOG. Serum levodopa levels were measured. Only those with ≥20% improvement in MDS-UPDRS-III score were included in analyses. Levodopa challenge was sufficient to bring about a full "ON" state with ≥20% improvement in 45 patients. Levodopa-equivalent-dose utilized was 142 ± 56% of patients' typical morning doses. Overall, 19/45 patients exhibited FOG in the full "ON" state (ONOFF-FOG), 11 were classified as OFF-FOG, and 15 NO-FOG. Linear mixed models revealed a highly significant association between serum levodopa level and total MDS-UPDRS-III score that was similar across groups. The ONOFF-FOG group exhibited significantly higher New-FOG-questionnaire and MDS-UPDRS-II scores compared to the OFF-FOG group. Among MDS-UPDRS-III subdomains significant effects of group (highest in ONOFF-FOG) were identified for other axial parkinsonian features. We found that FOG can persist in the full "ON" state brought about by ample dopaminergic dosing in PD. Other axial measures can also be levodopa-unresponsive among those with ONOFF-FOG only. These data provide evidence that ONOFF-FOG is distinct from responsive freezing.
    Language English
    Publishing date 2019-11-22
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2819218-7
    ISSN 2373-8057
    ISSN 2373-8057
    DOI 10.1038/s41531-019-0099-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: A clinical trial of safety and tolerability for the selective dopamine D1 receptor antagonist ecopipam in patients with Lesch-Nyhan disease.

    Khasnavis, Tanya / Reiner, Gail / Sommerfeld, Barbara / Nyhan, William L / Chipkin, Richard / Jinnah, H A

    Molecular genetics and metabolism

    2016  Volume 117, Issue 4, Page(s) 401–406

    Abstract: Lesch-Nyhan disease (LND) is an inherited metabolic disorder characterized by the overproduction of uric acid and distinct behavioral, cognitive, and motor abnormalities. The most challenging clinical problem is self-injurious behavior (SIB), which ... ...

    Abstract Lesch-Nyhan disease (LND) is an inherited metabolic disorder characterized by the overproduction of uric acid and distinct behavioral, cognitive, and motor abnormalities. The most challenging clinical problem is self-injurious behavior (SIB), which includes self-biting, self-hitting, self-abrasion, and other features. Currently, these behaviors are managed by behavioral extinction, sedatives, physical restraints, and removal of teeth. More effective treatments are needed. Pre-clinical studies have led to the hypothesis that D1-dopamine receptor antagonists may provide useful treatments for SIB in LND. Ecopipam is one such selective D1-dopamine receptor antagonist. This report summarizes results of a dose-escalation study of the safety and tolerability of ecopipam in 5 subjects with LND. The results suggest that ecopipam is well tolerated, with sedation being the most common dose-limiting event. Several exploratory measures also suggest ecopipam might reduce SIB in this population. These results support the hypothesis that D1-dopamine receptor antagonists may be useful for suppressing SIB in LND, and encourage further studies of efficacy.
    MeSH term(s) Adolescent ; Adult ; Benzazepines/administration & dosage ; Benzazepines/adverse effects ; Benzazepines/therapeutic use ; Child ; Dopamine Antagonists/administration & dosage ; Dopamine Antagonists/adverse effects ; Dopamine Antagonists/therapeutic use ; Humans ; Lesch-Nyhan Syndrome/diagnosis ; Lesch-Nyhan Syndrome/drug therapy ; Lesch-Nyhan Syndrome/metabolism ; Male ; Middle Aged ; Receptors, Dopamine D1/antagonists & inhibitors ; Self-Injurious Behavior ; Treatment Outcome ; Young Adult
    Chemical Substances Benzazepines ; Dopamine Antagonists ; Receptors, Dopamine D1 ; ecopipam (0X748O646K)
    Language English
    Publishing date 2016-04
    Publishing country United States
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1418518-0
    ISSN 1096-7206 ; 1096-7192
    ISSN (online) 1096-7206
    ISSN 1096-7192
    DOI 10.1016/j.ymgme.2016.02.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: A double-blind, placebo-controlled, crossover trial of the selective dopamine D1 receptor antagonist ecopipam in patients with Lesch-Nyhan disease.

    Khasnavis, Tanya / Torres, Rosa J / Sommerfeld, Barbara / Puig, Juan Garcia / Chipkin, Richard / Jinnah, H A

    Molecular genetics and metabolism

    2016  Volume 118, Issue 3, Page(s) 160–166

    Abstract: Lesch-Nyhan disease (LND) is a genetic disorder that has characteristic metabolic, neurologic, and behavioral features. There are multiple behavioral problems including impulsivity, aggressiveness, and severe recurrent self-injurious behavior (SIB). This ...

    Abstract Lesch-Nyhan disease (LND) is a genetic disorder that has characteristic metabolic, neurologic, and behavioral features. There are multiple behavioral problems including impulsivity, aggressiveness, and severe recurrent self-injurious behavior (SIB). This last behavior varies considerably across subjects and may encompass self-biting, self-hitting, scratching, head banging, and other injurious actions. Current treatments for SIB involve behavioral extinction, sedatives, physical restraints, and removal of teeth. Because these interventions do not reliably control SIB, better treatments are urgently needed. Animal studies have suggested that D1-dopamine receptor antagonists such as ecopipam may suppress SIB. These observations have led to proposals that such drugs might provide effective treatment for in LND. The current study describes the results of a double-blind, three-period, crossover trial of a single dose of ecopipam in subjects with LND. The study was designed for 20 patients, but it was terminated after recruitment of only 10 patients, because interim analysis revealed unanticipated side effects. These side effects were most likely related to starting with a single large dose without any titration phase. Despite the limited data due to early termination, the drug appeared to reduce SIB in most cases. Subjects who completed the trial were eligible to continue the drug in an open-label extension phase lasting a year, and one patient who elected to continue has maintained a striking reduction in SIB for more than a year with no apparent side effects. These results suggest ecopipam could be a useful treatment for SIB in, but further studies are needed to establish an appropriate dosing regimen.
    MeSH term(s) Adolescent ; Benzazepines/administration & dosage ; Benzazepines/adverse effects ; Child ; Cross-Over Studies ; Dopamine Antagonists/administration & dosage ; Dopamine Antagonists/adverse effects ; Double-Blind Method ; Humans ; Lesch-Nyhan Syndrome/drug therapy ; Male ; Sample Size ; Treatment Outcome ; Young Adult
    Chemical Substances Benzazepines ; Dopamine Antagonists ; ecopipam (0X748O646K)
    Language English
    Publishing date 2016-04-24
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1418518-0
    ISSN 1096-7206 ; 1096-7192
    ISSN (online) 1096-7206
    ISSN 1096-7192
    DOI 10.1016/j.ymgme.2016.04.012
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. 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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  6. 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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