A double-blind, randomized, placebo controlled study of the effects on wake EEG of 2 doses of naftidrofuryl using a cross-over design in elderly healthy male volunteers

Boeijinga, Peter H.; Muzet, Muriel; D’Aniello, Fabiana; Parot, P.; Luthringer, R.; Mâcher, Jean-Paul; Gamand, S

doi:10.1016/s0924-977x(00)80481-2

Cited by 2 publications

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“…An example of the effect of a noncholinergic drug is given in Figure 5 (bottom). 30 Indeed, a clear-cut indication of recovery can be observed, even though the increase in absolute terms is modest.…”

Section: Proof Of Conceptmentioning

confidence: 96%

Objective markers of drug effects on brain function from recordings of scalp potential in healthy volunteers

Boeijinga

2002

Dialogues in Clinical Neuroscience

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In order to stress the importance of P300 responses in drug development, we describe the spatiotemporal characteristics of this objective, evoked event-related potential. These brain activations reflect mnemonic function, in which limbic structures play a role. It is demonstrated that a pharmacological challenge concerning, for example, the cholinergic system in young healthy volunteers induces modifications in P300 reminiscent of the aging brain. We use this type of observation to build a model in which it can be verified whether the deterioration can be counteracted by treatment with "cognition-enhancing" drugs. If we accept the extrapolation of the pharmacological effects to symptomatology, scalp potential analysis offers an appropriate tool for the study of drug interactions in early proof-of-concept models.

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Section: Proof Of Conceptmentioning

confidence: 96%

Objective markers of drug effects on brain function from recordings of scalp potential in healthy volunteers

Boeijinga

2002

Dialogues in Clinical Neuroscience

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Human models as tools in the development of psychotropic drugs

Gilles

Schunck²,

Erb³

et al. 2002

Dialogues in Clinical Neuroscience

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Despite the growing means devoted to research and development (R α D) and refinements in the preclinical stages, the efficiency of central nervous system (CMS) drug development is disappointing. Many drugs reach patient studies with an erroneous therapeutic indication andlor in incorrect doses. Apart from the first clinical studies, which are conducted in healthy volunteers and focus only on safety, iolerability, and pharmacokinetics, drug development mostly relies on patient studies. Psychiatric disorders are characterized by heterogeneity and a high rate of comorbidity. It is becoming increasingly difficult to recruit patients for clinical trials and there are many confounding factors in this population, for example, those related to treatments. In order to keep patient exposure and financial expenditure to a minimum, it is important to avoid ill-designed and inconclusive studies. This risk could be minimized by gathering pharmacodynamic data earlier in development and considering that the goal of a phase 1 plan is to reach patient studies with clear ideas about the compound's pharmacodynamic profile, its efficacy in the putative indication (proof of concept), and pharmacokinetic/pharmacodynamic relationships, in addition to safety, tolerability, and pharmacokinetics. Human models in healthy volunteers may be useful tools for this purpose, but their use necessitates a global adaptation of the phase scheme, favoring pharmacodynamic assessments without neglecting safety. We are engaged in an R α D program aimed to adapt existing models and develop new paradigms suitable for early proof of concept substantiation.

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A double-blind, randomized, placebo controlled study of the effects on wake EEG of 2 doses of naftidrofuryl using a cross-over design in elderly healthy male volunteers

Cited by 2 publications

References 0 publications

Objective markers of drug effects on brain function from recordings of scalp potential in healthy volunteers

Objective markers of drug effects on brain function from recordings of scalp potential in healthy volunteers

Human models as tools in the development of psychotropic drugs

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