This database contains 1231 studies, archived under the term: "humans"
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Memantine and brain atrophy in Alzheimer’s disease: a 1-year randomized controlled trial
Wilkinson, David,
Fox, Nick C.,
Barkhof, Frederik,
Phul, Ravinder,
Lemming, Ole,
Scheltens, Philip
The primary objective of this study was to evaluate the rate of total brain atrophy (TBA) with serial magnetic resonance imaging (MRI), using the Brain Boundary Shift Integral (BBSI), in patients with probable Alzheimer’s disease (AD) over the course of 52 weeks of treatment with memantine or placebo. This was a multi-national, randomized, double-blind, placebo-controlled, […]
Safety, tolerability, and antibody response of active Aβ immunotherapy with CAD106 in patients with Alzheimer’s disease: randomised, double-blind, placebo-controlled, first-in-human study
Winblad, Bengt,
Andreasen, Niels,
Minthon, Lennart,
Floesser, Annette,
Imbert, Georges,
Dumortier, Thomas,
Maguire, R. Paul,
Blennow, Kaj,
Lundmark, Joens,
Staufenbiel, Matthias,
Orgogozo, Jean-Marc,
Graf, Ana
Background: Immunotherapy targeting the amyloid β (Aβ) peptide is a potential strategy to slow the progression of Alzheimer’s disease. We aimed to assess the safety and tolerability of CAD106, a novel active Aβ immunotherapy for patients with Alzheimer’s disease, designed to induce N-terminal Aβ-specific antibodies without an Aβ-specific T-cell response.; Methods: We did a phase […]
Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)
Clare, Linda,
Bayer, Antony,
Burns, Alistair,
Corbett, Anne,
Jones, Roy,
Knapp, Martin,
Kopelman, Michael,
Kudlicka, Aleksandra,
Leroi, Iracema,
Oyebode, Jan,
Pool, Jackie,
Woods, Bob,
Whitaker, Rhiannon
Background: Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer’s disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers.; Methods/design: In this multi-centre, single-blind […]
The Mental Activity and eXercise (MAX) trial: a randomized controlled trial to enhance cognitive function in older adults
Barnes, Deborah E.,
Santos-Modesitt, Wendy,
Poelke, Gina,
Kramer, Arthur F.,
Castro, Cynthia,
Middleton, Laura E.,
Yaffe, Kristine
Importance: The prevalence of cognitive impairment and dementia are projected to rise dramatically during the next 40 years, and strategies for maintaining cognitive function with age are critically needed. Physical or mental activity alone result in relatively small, domain-specific improvements in cognitive function in older adults; combined interventions may have more global effects.; Objective: To […]
Study of the use of antidepressants for depression in dementia: the HTA-SADD trial–a multicentre, randomised, double-blind, placebo-controlled trial of the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine
Banerjee, S.,
Hellier, J.,
Romeo, R.,
Dewey, M.,
Knapp, M.,
Ballard, C.,
Baldwin, R.,
Bentham, P.,
Fox, C.,
Holmes, C.,
Katona, C.,
Lawton, C.,
Lindesay, J.,
Livingston, G.,
McCrae, N.,
Moniz-Cook, E.,
Murray, J.,
Nurock, S.,
Orrell, M.,
O'Brien, J.,
Poppe, M.,
Thomas, A.,
Walwyn, R.,
Wilson, K.,
Burns, A.
Objective: Depression is common in dementia, causing considerable distress and other negative impacts. Treating it is a clinical priority, but the evidence base is sparse and equivocal. This trial aimed to determine clinical effectiveness of sertraline and mirtazapine in reducing depression 13 weeks post randomisation compared with placebo.; Design: Multicentre, parallel-group, double-blind placebo-controlled randomised controlled […]
Antioxidants for Alzheimer disease: a randomized clinical trial with cerebrospinal fluid biomarker measures
Galasko, Douglas R,
Peskind, Elaine,
Clark, Christopher M.,
Quinn, Joseph F.,
Ringman, John M.,
Jicha, Gregory A.,
Cotman, Carl,
Cottrell, Barbara,
Montine, Thomas J.,
Thomas, Ronald G.,
Aisen, Paul
Objective: To evaluate whether antioxidant supplements presumed to target specific cellular compartments affected cerebrospinal fluid (CSF) biomarkers.; Design: Double-blind, placebo-controlled clinical trial.; Setting: Academic medical centers.; Participants: Subjects with mild to moderate Alzheimer disease.; Intervention: Random assignment to treatment for 16 weeks with 800 IU/d of vitamin E (α-tocopherol) plus 500 mg/d of vitamin C […]
Pilot randomized controlled study of a histamine receptor inverse agonist in the symptomatic treatment of AD
Egan, Michael,
Yaari, Roy,
Liu, Lian,
Ryan, Michael,
Peng, Yahong,
Lines, Christopher,
Michelson, David
We performed a clinical trial to evaluate the effects of the histamine subtype-3 receptor inverse agonist MK- 0249 on cognition in AD patients. Mild-to-moderate AD patients were randomized 1:1 to 4 weeks of double-blind daily treatment with oral MK-0249 5-mg or placebo. Pharmacokinetic and PET data suggested that MK-0249 5-mg daily would achieve approximately 85% […]
Donepezil in Parkinson’s disease dementia: a randomized, double-blind efficacy and safety study
Dubois, Bruno,
Tolosa, Eduardo,
Katzenschlager, Regina,
Emre, Murat,
Lees, Andrew J.,
Schumann, Günther,
Pourcher, Emmanuelle,
Gray, Julian,
Thomas, Gail,
Swartz, Jina,
Hsu, Timothy,
Moline, Margaret L.
Parkinson’s disease dementia (PDD) is associated with cholinergic deficits. This report presents an efficacy and safety study of the acetylcholinesterase inhibitor donepezil hydrochloride in PDD. PDD patients (n = 550) were randomized to donepezil (5 or 10 mg) or placebo for 24 weeks. Coprimary end points were the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and […]
Optimised anaesthesia to reduce post operative cognitive decline (POCD) in older patients undergoing elective surgery, a randomised controlled trial
Ballard, Clive,
Jones, Emma,
Gauge, Nathan,
Aarsland, Dag,
Nilsen, Odd Bjarte,
Saxby, Brian K.,
Lowery, David,
Corbett, Anne,
Wesnes, Keith,
Katsaiti, Eirini,
Arden, James,
Amoako, Derek,
Prophet, Nicholas,
Purushothaman, Balaji,
Green, David
Background: The study determined the one year incidence of post operative cognitive decline (POCD) and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age) undergoing elective orthopaedic or abdominal surgery.; Methods and Trial Design: The design was a prospective cohort study with a […]