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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Study Designs in Epidemiology01:20

Study Designs in Epidemiology

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Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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Screening over Speech in Unselected Populations for Clinical Trials in AD (PROSPECT-AD): Study Design and Protocol.

A König1, N Linz, E Baykara

  • 1Alexandra König, ki:elements GmbH, Am Holzbrunnen 1a, D-66121 Saarbrücken,

The Journal of Prevention of Alzheimer'S Disease
|March 22, 2023
PubMed
Summary

Speech analysis offers a novel digital biomarker for early Alzheimer's disease (AD) detection. The PROSPECT-AD study validates these speech markers for screening and monitoring individuals at risk of dementia.

Keywords:
Alzheimer’s diseaseDementiacognitive assessmentmachine learningphone-basedscreeningspeech biomarker

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A Machine Learning Approach to Design an Efficient Selective Screening of Mild Cognitive Impairment
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Area of Science:

  • Neuroscience
  • Computational Linguistics
  • Gerontology

Background:

  • Speech impairments are an early indicator of Alzheimer's disease (AD).
  • Analyzing speech performance presents a promising digital biomarker for AD screening.
  • Early identification of individuals at risk of dementia is crucial for future AD drug trials.

Purpose of the Study:

  • To validate speech biomarkers for identifying individuals with early signs of Alzheimer's disease (AD).
  • To monitor the longitudinal course of AD through speech data.
  • To develop a remote screening tool for AD risk populations.

Main Methods:

  • Leveraging existing European cohorts (EPAD, DESCRIBE, DELCODE, BioFINDER, Beta-AARC) to collect speech data via telephone.
  • Recruiting participants at risk of dementia across an AD 'probability-spectrum'.
  • Administering remote neurocognitive speech tests (Word List, Verbal Fluency, spontaneous speech) and extracting linguistic/paralinguistic features.

Main Results:

  • Speech features will be compared against established biomarkers (CSF, blood, neuroimaging, genetics).
  • Machine learning will identify significant speech biomarkers for early AD pathology detection.
  • Models will be trained to predict cognitive decline and disease progression using speech performance.

Conclusions:

  • PROSPECT-AD may support AD drug development by providing a validated remote screening tool.
  • The study aims to facilitate early identification and monitoring of individuals at risk of dementia.
  • Validated speech markers can be used in screening or clinical trial contexts.