One-hundred and ninety-four children (11 +/- 1.5 years of age), 43 young adult subjects (21 +/- 2 years of age) and 149 elderly subjects studied in 278-24 hour profiles (77 +/- 8 years of age) were studied over one or several 24-hour spans. All subjects followed a diurnal activity pattern with rest during the night. Blood and urine were collected at 4-hour intervals over a 24-hour span (6 samples). The circadian rhythms of 22 endocrine parameters were explored in plasma and five in urine. In the children and the elderly subjects, the investigations extended over all four seasons allowing also the study of seasonal variations or circannual rhythms. The circadian rhythms were characterized by population mean cosinor for each group of subjects. The circannual rhythms were explored by single cosinor, by one and two way analysis of variance applied to the circadian means obtained during each season and by comparison of the circadian rhythm parameters obtained during the four seasons by the parameter test described by Bingham et al. Circadian rhythms were found in most and circannual rhythms in many parameters. The rhythm characteristics are presented as cosinor summaries and acrophase charts. Although there were certain differences in some rhythm parameters between the age groups, the elderly showed a remarkable maintenance of their circadian time structure. In the circannual frequency range, the elderly men showed more circannual periodicity as group phenomenon than the women. Many endocrine rhythms show high amplitude rhythms which have to be taken into account in the selection of the time for endocrine testing and in the interpretation of the results.
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Amyloid-β 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials.
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From Janssen Alzheimer Immunotherapy Research & Development, LLC (E.L., R.M., P.C., K.M.G., J.D., Y.L., I.C.T., S.B., E.Y., H.R.B.), South San Francisco, CA; Janssen Pharmaceutical (M.E.S.), Beerse, NV; Brigham & Women's Hospital (R.S.), Boston, MA; University of Michigan (R.K.), Ann Arbor; University of Pittsburgh (N.S.M., W.E.K., C.A.M.), PA; Butler Hospital (S.S.), Providence, RI; UCL Institute of Neurology (N.C.F.), London, UK; IXICO plc (D.L.H., A.S.L.), London, UK; Pfizer Inc. (B.T.W.), Groton, CT; Pfizer Inc. (K.B.), Collegeville, PA; Global R&D Partners, LLC (M.G.), San Diego, CA; and University of California (M.G.), San Diego.
Objective: To evaluate the effects of bapineuzumab on brain β-amyloid (Aβ) burden using (11)C-Pittsburgh compound B ((11)C-PiB)-PET.
Methods: Two phase 3 clinical trials, 1 each in apolipoprotein APOE ε4 carriers and noncarriers, were conducted in patients with mild to moderate Alzheimer disease dementia. Bapineuzumab, an anti-Aβ monoclonal antibody, or placebo, was administered by IV infusion every 13 weeks for 78 weeks.
Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease.
N Engl J Med
January 2014
From Butler Hospital, Providence, RI (S.S.); Brigham and Women's Hospital, Boston (R.S.); University College London, Institute of Neurology, London (N.C.F.); University of Göteborg, Sahlgrenska University Hospital, Mölndal, Sweden (K.B.); University of Pittsburgh, Pittsburgh (W.K.); Veterans Affairs Medical Center, Seattle (M.R.); Cleo Roberts Center for Clinical Research/Sun Health Research Institute, Sun City, AZ (M.S.); Columbia University (L.S.H.) and New York University Langone Medical Center (S.F.), New York; University of Rochester School of Medicine and Dentistry, Rochester, NY (A.P.P.); Janssen Alzheimer Immunotherapy Research and Development, South San Francisco, CA (M.R., N.K., B.N., V.G., M.M., D.W., Y.L., I.C.T., E.L., E.Y., H.R.B.); Janssen Research and Development, Titusville, NJ (J.L.); Global R&D Partners and the University of California, San Diego - both in San Diego (M.G.); and Pfizer, Collegeville, PA (R.B.).
Background: Bapineuzumab, a humanized anti-amyloid-beta monoclonal antibody, is in clinical development for the treatment of Alzheimer's disease.
Methods: We conducted two double-blind, randomized, placebo-controlled, phase 3 trials involving patients with mild-to-moderate Alzheimer's disease--one involving 1121 carriers of the apolipoprotein E (APOE) ε4 allele and the other involving 1331 noncarriers. Bapineuzumab or placebo, with doses varying by study, was administered by intravenous infusion every 13 weeks for 78 weeks.
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