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

279
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...
279
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

"A little bit of masking tape and a lot of glitter": Perspectives of older LGBT+ Australians on navigating aged care.

Geriatric nursing (New York, N.Y.)·2026
Same author

Aged and Health Care Service Use by Older Australians Who Identify as Lesbian, Gay, Bisexual, Transgender, Intersex or Gender Diverse: A Retrospective Cohort Study.

Journal of homosexuality·2026
Same author

Manual wheelchair training for individuals with chronic and progressive conditions: a critical realist approach to improving practice.

BMC health services research·2025
Same author

Drug Development.

Alzheimer's & dementia : the journal of the Alzheimer's Association·2025
Same author

Using AI-generated digital twins to boost clinical trial efficiency in Alzheimer's disease.

Alzheimer's & dementia (New York, N. Y.)·2025
Same author

Using Nominal Group Technique to Gather Recommendations in the Decision-Making for Amputation Due to Diabetes.

Journal of foot and ankle research·2025
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.

Coco Kusiak1, Rachel Mak-McCully1, Carolyn Murray1

  • 1Unlearn.AI, San Francisco, CA, USA.

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

Digital twins can reduce Alzheimer's disease trial sample sizes by up to 24% or increase power for secondary endpoints. This approach enhances statistical efficiency in clinical trials for treatments like donanemab.

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

451

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

451

Area of Science:

  • Neuroscience
  • Clinical Trials
  • Biostatistics

Background:

  • The TRAILBLAZER-ALZ 2 trial showed donanemab effectively reduced amyloid plaques and slowed cognitive decline in early Alzheimer's disease.
  • However, secondary endpoints and subgroup analyses were underpowered.
  • Prognostic covariates, like digital twins, can improve statistical power and reduce sample size requirements.

Purpose of the Study:

  • To simulate the TRAILBLAZER-ALZ 2 trial and quantify the sample size reduction or power gain from incorporating participant digital twins.
  • To assess the impact of digital twins on the statistical analysis of Alzheimer's disease clinical trial data.

Main Methods:

  • A synthetic dataset was created mirroring the TRAILBLAZER-ALZ 2 cohort, with participants randomized 1:1.
  • Donanemab treatment effects were simulated.
  • Participant digital twins were generated using Unlearn's Alzheimer's Disease Digital Twin Generator.

Main Results:

  • Incorporating digital twins as covariates could have reduced the TRAILBLAZER-ALZ 2 control arm by up to 24% for the primary outcome (iADRS at 18 months).
  • Digital twins could increase statistical power for secondary endpoints by up to 15%.
  • Subgroup analyses also demonstrated increased power.

Conclusions:

  • Digital twins, when used as supercovariates, can significantly reduce sample size or enhance power in Alzheimer's disease clinical trials.
  • This method improves the efficiency of analyzing primary, secondary, and subgroup endpoints.
  • Digital twins offer a valuable tool for optimizing clinical trial design and analysis in Alzheimer's research.