Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

5.7K
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...
5.7K
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.5K
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...
4.5K
Drug Discovery: Overview01:26

Drug Discovery: Overview

10.9K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
10.9K
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.1K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.1K
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

269
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
269
Drug Regulation01:25

Drug Regulation

2.7K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.7K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Regional mapping of CSF1R-positive microglia in neurodegenerative diseases and progressive MS, with exploratory presynaptic marker analyses.

Journal of neuroinflammation·2026
Same author

Characterisation of Posterior Predominant Amyloid PET Binding Across Multiple Cohorts.

bioRxiv : the preprint server for biology·2026
Same author

Prior Traumatic Brain Injury and Alzheimer Disease Blood Biomarkers.

JAMA neurology·2026
Same author

Identification of patients receiving amyloid-targeting therapies in observational studies using amyloid PET trajectories: Insights from LEADS.

Alzheimer's & dementia (Amsterdam, Netherlands)·2026
Same author

Improving the clinical trial landscape for patients with atypical variants of Alzheimer's disease: a call to action.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same author

Functional network contributions to longitudinal tau spread in Posterior Cortical Atrophy.

NPJ dementia·2026
Same journal

Unveiling the procoagulant state in Alzheimer's disease: A novel PET imaging strategy.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Estimated labor market outcomes of people progressing from preclinical to early-stage Alzheimer's disease in the United States.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Amyloid exacerbates tau and alpha-synuclein pathologies, behavioral impairments, and neuroinflammation in a mixed dementia model.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Multimorbidity burden and patterns associated with DeepBrainNet-derived brain-age gap in dementia-free older adults: A community-based study.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Reply to "Shifting the emphasis of brain health literacy from individuals to systems to reduce inequalities".

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
Same journal

Shifting the emphasis of brain health literacy from individuals to systems to reduce inequalities.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2026
See all related articles

Related Experiment Video

Updated: Jan 7, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

10.1K

Drug Development.

Gil D Rabinovici1

  • 1UCSF Alzheimer's Disease Research Center, San Francisco, CA, USA; Memory and Aging Center, Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
This summary is machine-generated.

Appropriate Use Recommendations (AUR) guide donanemab use in early Alzheimer's disease (AD). These guidelines prioritize safety and effectiveness for patients with biomarker-supported AD, ensuring proper implementation of this novel amyloid-beta targeting therapy.

More Related Videos

In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing
08:04

In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing

Published on: May 11, 2021

3.3K
Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
05:45

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

446

Related Experiment Videos

Last Updated: Jan 7, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

10.1K
In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing
08:04

In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing

Published on: May 11, 2021

3.3K
Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells
05:45

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

446

Area of Science:

  • Neurology
  • Pharmacology
  • Biotechnology

Background:

  • Donanemab, an IgG1 monoclonal antibody, targets pyroglutamate-modified amyloid-beta for early Alzheimer's disease (AD) treatment.
  • Appropriate Use Recommendations (AUR) are established to guide donanemab's real-world clinical implementation.
  • The recommendations prioritize patient safety and treatment effectiveness.

Purpose of the Study:

  • To develop practical guidelines for the safe and effective use of donanemab in clinical practice.
  • To translate donanemab clinical trial criteria into real-world application.
  • To inform clinicians on patient selection, monitoring, and treatment discontinuation.

Main Methods:

  • The AUR were developed by the AD and Related Disorders Therapeutic Workgroup.
  • Expert opinion and comprehensive review of available efficacy, safety, and Aβ-targeting antibody data were integrated.
  • Consensus was achieved through iterative refinement via video conferences and written exchanges from October 2023 to November 2024.

Main Results:

  • Donanemab is indicated for early AD (mild cognitive impairment or mild dementia, MMSE 20-30) with biomarker support.
  • Apolipoprotein E genotyping is required; pre-treatment MRI is necessary to exclude contraindications like significant cerebral amyloid angiopathy.
  • Treatment involves monthly IV infusions with regular MRI monitoring for Amyloid Related Imaging Abnormalities (ARIA); discontinuation may be considered upon demonstrated amyloid clearance.

Conclusions:

  • The AUR adapt donanemab clinical trial protocols for practical patient care, aiming to maximize safe and effective translation of the therapy.
  • These recommendations are expected to evolve with accumulating real-world data from patient registries.
  • The guidelines facilitate the integration of donanemab into routine clinical practice for managing early-stage Alzheimer's disease.