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This database contains 57 studies, archived under the term: "adverse events"

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A randomized feasibility study of a 12-week community-based exercise program for people with Huntington’s disease
BACKGROUND AND PURPOSE: The beneficial role of exercise as a treatment approach in Huntington’s disease (HD) has support from both preclinical work and small-scale studies; however, there have been no controlled studies of gym-based exercise in people with HD. This phase 2 randomized trial (ISRCTN 59910670) assessed feasibility, safety, acceptability, and benefit of a structured […]

Memantine for dementia in adults older than 40 years with Down’s syndrome (MEADOWS): a randomised, double-blind, placebo-controlled trial
Background: Prevalence of Alzheimer’s disease in people with Down’s syndrome is very high, and many such individuals who are older than 40 years have pathological changes characteristic of Alzheimer’s disease. Evidence to support treatment with Alzheimer’s drugs is inadequate, although memantine is beneficial in transgenic mice. We aimed to assess safety and efficacy of memantine […]

Efficacy of memantine for agitation in Alzheimer’s dementia: a randomised double-blind placebo controlled trial
Background: Agitation in Alzheimer’s disease (AD) is common and associated with poor patient life-quality and carer distress. The best evidence-based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality. There are no memantine trials in clinically significant agitation but post-hoc analyses in other populations found reduced agitation. We tested the primary […]

Memantine and brain atrophy in Alzheimer’s disease: a 1-year randomized controlled trial
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
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 […]

Pilot randomized controlled study of a histamine receptor inverse agonist in the symptomatic treatment of AD
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
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 […]

Efficacy of Souvenaid in mild Alzheimer’s disease: results from a randomized, controlled trial
Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer’s disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naïve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind, parallel-group, multi-country trial to confirm and extend previous findings in drug-naïve patients with […]

Transcendental Meditation for the improvement of health and wellbeing in community-dwelling dementia caregivers TRANSCENDENT: a randomised wait-list controlled trial
BACKGROUND: Dementia is a prevalent neurodegenerative disorder affecting an estimated 24.3 million people across the globe. The burden on those caring for people with dementia is substantial, with widespread implications for the caregiver, the care recipient and the community. Relaxation techniques, such as Transcendental Meditation(R) (TM), have been shown to reduce stress and anxiety in […]

Memantine for patients with Parkinson’s disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial
Background: Previous studies have suggested that patients with Lewy-body-related dementias might benefit from treatment with the N-methyl D-aspartate receptor antagonist memantine, but further data are needed. Therefore, the efficacy and safety of memantine were investigated in patients with mild to moderate Parkinson’s disease dementia (PDD) or dementia with Lewy bodies (DLB).; Methods: Patients (≥50 years […]

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