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Bumetanide in Autism Medication and Biomarker study

The primary objective of the proposed study is to investigate whether bumetanide therapy indeed reduces autistic symptomatology. Important secondary goals of this project are to determine whether bumetanide will improve specific behavioral,…

A Phase 1 Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Study of KHK6640 in Alzheimer's Disease

Primary objective: Single-ascending dose (SAD) and multiple-ascending dose (MAD) phases of the study: *To establish the safety and tolerability of single- and multiple-ascending dose(s) of KHK6640, respectively, in subjects with prodromal Alzheimer*…

A Phase 2A Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Trial of PQ912 in Subjects with early Alzheimer's Disease

To assess the safety and tolerability of multiple doses of PQ912 compared with placebo in subjects with early stage of Alzheimers Disease.

Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients with Mild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease

Assessment of Safety, Tolerability, and Pharmacodynamic Effects of LY2886721 in Patients withMild Cognitive Impairment Due to Alzheimer*s Disease or Mild Alzheimer's Disease

A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer*s Disease

Objectives:Primary Objectives:1. To evaluate the efficacy of BAN2401 compared to placebo by establishing the ED90 (as defined in theprotocol) for BAN2401 on the derived Composite Clinical Score at 12 months of treatment in subjects withEarly…

A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of AFQ056 in adolescent patients with Fragile X Syndrome

The purpose of the study is to assess the efficacy and safety in adolescents of AFQ056 in treating behavioral symptoms characteristic of patients with FXS. Data from this study will be used to support the registration of AFQ056 in this population…

A double-blind, placebo-controlled, five-way partial crossover study with EVP-6124 and donepezil in the scopolamine challenge model in healthy elderly volunteers

Primary Objectives:• Assess the pharmacokinetic (PK) and pharmacodynamic (PD)/efficacy effects of 3 different single doses of EVP-6124 vs. placebo;• Assess the PK and PD/efficacy effects of the different combinations of 2 doses of donepezil and 3…

A randomized, double-blind, double-dummy, placebo-controlled, single dose, 4-way cross-over study of the reversibility of cognitive deficits induced by a nicotinic anti-cholinergic challenge with mecamylamine by a cholinesterase inhibitor and a nicotinic receptor agonist

Primary Objectives • To demonstrate if the impairment of cognitive function caused by mecamylamine administration can be diminished by an nAChR agonist or CEI.• To evaluate to what extent a single dose of 30 mg mecamylamine may cause a more…

A two-part study to evaluate the safety, pharmacokinetics, pharmacodynamics of HTL0009936 in healthy elderly and elderly with below average cognitive functioning.

The objective of the present study is to assess the effect of HTL0009936 on cognitive performance in elderly subjects with below average cognitive function. The oral pharmacokinetics of HTL0009936 shows a significant degree of variability between…

A Double-Blind, Placebo-Controlled, Randomized, Parallel Group, 12-Month Safety and Efficacy Trial of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Behavioral Variant Frontotemporal Dementia (bvFTD)

Primary:To demonstrate the efficacy of LMTM as assessed by the change from Baseline on:* Addenbrooke*s Cognitive Examination Revised (ACE-R)* Symptomatic effect as reflected by the Functional Activities Questionnaire (FAQ)* Disease-modifying effect…

A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).

Primary• To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician*s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment• To assess the effects of RVT-101 versus…

Randomized, double-blind, placebo-controlled, 3-way cross-over study to characterize the pharmacodynamics and pharmacokinetics of single-dose intravenously administered biperiden in healthy elderly male and female subjects

- Characterization of the CNS PD profile of IV administered biperiden- Characterization of the pharmacokinetic profile of IV administered biperiden- To confirm the plasma concentration-effect relationship of biperiden using population PK-PD modeling…

Bumetanide for the Autism Spectrum Clinical Effectiveness Trial

The primary objective of the study is to test the effectiveness of bumetanide across the whole spectrum of sensory processing disorders within ASD, ADHD and/or epilepsy. We also want to determine which subgroups (high/low IQ, comorbidities or not)…

Randomized, double-blind, placebo-controlled, two way crossover, single centre study evaluating the acute and chronic effect of clonazepam on cognitive tests and patient-reported outcome measures in patients with ARID1B-related intellectual disability

* To test the hypothesis that clonazepam administration has acute beneficial effects compared to placebo on body sway, adaptive tracking, smooth eye pursuit, tapping frequency and the animal fluency test.* To test the hypothesis that multiple-doses…

Gut-brain health effects of PREbiotics in older adults with suspected
COgnitive DEcline: the PRECODE study

The primary objective of this study is to investigate the effect of 26 weeks of supplementation with three different dietary fibres (chicory inulin, resistant dextrin, and seaweed polysaccharide) compared to a placebo (maltodextrin) on microbiota…

A Randomized, Double-Blind, Placebo-Controlled Study, Followed by an Open-Label Extension, to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ISIS 814907 in Patients with Mild Alzheimer*s Disease

Primary Objective:To evaluate the safety and tolerability of ascending dose-levels of multiple intrathecal (IT) bolus administrations of ISIS 814907 to patients with mild ADSecondary Objective:To characterize the cerebrospinal fluid (CSF)…

A Phase 2b/3, Double-Blind, Randomised, Placebo-Controlled 48-week Safety and Efficacy trial of ANAVEX2-73 for the Treatment of Early Alzheimer*s Disease (AD).

Primary Objectives:* Change from baseline to week 48 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) compared to placebo.* Changes from baseline to week 48 in ability to perform daily activities according to the…

Randomized, double-blind, placebo-controlled, 2-way crossover study to characterize pharmacological reversal of biperiden-induced cognitive effects by donepezil in healthy elderly subjects

Primary objective• Assess the ability of donepezil to reverse biperiden-induced effects on adaptive tracking performance at timepoint 4h Secondary objectives• Evaluate the PK of donepezil and biperiden• Investigation of pro-cholinergic effects of…

A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer*s type.

The primary objective is to:* Evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo for thetreatment of agitation in patients with dementia of the Alzheimer*s typeThe secondary objectives are to:* Evaluate the effects of AVP…

A Phase 3, multi-center, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy and safety of sodium oligomannate (GV-971) in treatment of mild to moderate Alzheimer's disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)

To assess the efficacy of GV-971 compared with placebo on cognition and global function in participants with mild to moderate Alzheimer's disease (AD).