Alzheimer's disease - input of vitamin D with mEmantine assay (AD-IDEA trial): study protocol for a randomized controlled trial

BACKGROUND: Current treatments for Alzheimer\u27s disease and related disorders (ADRD) are symptomatic and can only temporarily slow down ADRD. Future possibilities of care rely on multi-target drugs therapies that address simultaneously several pathophysiological processes leading to neurodegeneration. We hypothesized that the combination of memantine with vitamin D could be neuroprotective in ADRD, thereby limiting neuronal loss and cognitive decline. The aim of this trial is to compare the effect after 24 weeks of the oral intake of vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive performance in patients suffering from moderate ADRD and receiving memantine. METHODS: The AD-IDEA Trial is a unicentre, double-blind, randomized, placebo-controlled, intent-to-treat, superiority trial. Patients aged 60 years and older presenting with moderate ADRD (i.e., Mini-Mental State Examination [MMSE] score between 10-20), hypovitaminosis D (i.e., serum 25-hydroxyvitamin D [25OHD] < 30 ng/mL), normocalcemia (i.e., serum calcium < 2.65 mmol/L) and receiving no antidementia treatment at time of inclusion are being recruited. All participants receive memantine 20 mg once daily -titrated in 5 mg increments over 4 weeks- and each one is randomized to one of the two treatment options: either cholecalciferol (one 100,000 IU drinking vial every 4 weeks) or placebo (administered at the same pace). One hundred and twenty participants are being recruited and treatment continues for 24 weeks. Primary outcome measure is change in cognitive performance using Alzheimer\u27s Disease Assessment Scale-cognition score. Secondary outcomes are changes in other cognitive scores (MMSE, Frontal Assessment Battery, Trail Making Test parts A and B), change in functional performance (Activities of Daily Living scale, and 4-item Instrumental Activities of Daily Living scale), posture and gait (Timed Up & Go, Five Time Sit-to-Stand, spatio-temporal analysis of walking), as well as the between-groups comparison of compliance to treatment and tolerance. These outcomes are assessed at baseline, 12 and 24 weeks, together with the serum concentrations of 25OHD, calcium and parathyroid hormone. DISCUSSION: The combination of memantine plus vitamin D may represent a new multi-target therapeutic class for the treatment of ADRD. The AD-IDEA Trial seeks to provide evidence on its efficacy in limiting cognitive and functional declines in ADRD. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT01409694

Third molar treatment outcome: a comparison of patients' preferences in Sweden and Wales.

Aim: To elucidate and compare patients’ outcome preferences with regard to removal and retention of mandibular third molars in Sweden and Wales. Subjects and Method: The subjects comprised patients referred for and scheduled for removal of one or both mandibular third molars in both Sweden and Wales. To study patients’ preferences for outcomes of removal and retention of the mandibular third molar, the Multi-attribute utility (MAU) methodology was applied to these patients. Results: Relative weighting of domains was similar in the two countries. “Home and social life” received the highest relative weighting in Sweden and “General health and well-being” in Wales. “Your appearance” received the lowest relative weighting in Sweden and Wales. In both Sweden and Wales operative jaw fracture was considered to be the outcome with most impact and dentigerous cyst and imbricated incisors the least impact. Outcome ranking was similar in the two countries and operative outcomes were considered by patients to be more detrimental to health than retention outcomes. Conclusions: This European comparison showed that patients’ preferences in Sweden and Wales were similar and that the outcomes of surgery were considered worse after third molar removal than retention. Patient-orientated treatment decisions are less subject to variation than clinician-orientated decisions

Therapeutic elastic tape reduces morbidity after wisdom teeth removal—a clinical trial

ObjectivesAlthough the extraction of an impacted third molar (3M) is a routine procedure, postoperative morbidities typically include swelling, pain, and trismus. The aim of the present study was to investigate whether the application of kinesiologic tape can improve the postoperative morbidities associated with 3M surgery, thereby improving the postoperative well-being of patients.Materials and methodsForty patients assigned for prospective 3M removal were randomized into two treatment groups (with/without kinesiologic tape). Facial swelling was quantified using a five-line measurement at six specific time points. Pain scores were assessed using a visual analog scale, and mouth opening range was assessed by means of standard calipers. In addition, all patients were asked to evaluate overall satisfaction and swelling (both groups) and the effect of the tape on movement and comfort (taped group only).ResultsThe postoperational application of kinesiologic tape reduced significantly all investigated parameters: swelling, pain, and trismus. Furthermore, patients with kinesiologic tape reported a significantly lower morbidity rate.ConclusionThe application of kinesiologic tape following a 3M surgery is a simple and economical, yet medically relevant approach.Clinical relevanceKinesiologic tape offers patients a less traumatic postoperational experience and therefore holds promise to enhance the quality of life of a large cohort of the population