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

Pimavanserin for Irritability in Children and Adolescents With Autism Spectrum Disorder: Phase 2 Randomized Trial.

Journal of the American Academy of Child and Adolescent Psychiatry·2026
Same author

Population pharmacokinetics of remlifanserin (ACP-204), a serotonin 2A receptor inverse agonist.

Alzheimer's & dementia (New York, N. Y.)·2026
Same author

A Phase 1, Randomized, Open-Label Study to Assess the Bioequivalence of Trofinetide as a Ready-to-Use Oral Solution and Constituted Powder for Oral Solution in Healthy Adults.

Advances in therapy·2026
Same author

Drug Development.

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

Drug Development.

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

Drug Development.

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

Evidence for progressive neurodegeneration in iatrogenic cerebral amyloid angiopathy.

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

Human brain connectome profiles mediate the relationship between pathology burden and clinical phenotypes in Alzheimer's disease.

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

Kat5 cKO mouse replicates biological domain signatures associated with Alzheimer's disease.

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

Evaluation of CSF and plasma tau species as fluid surrogate candidates for tau PET in prodromal to moderate Alzheimer's disease.

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

Associations of self-reported obstructive sleep apnea with cognition and dementia risk in cognitively unimpaired middle-aged adults.

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

Inflammation profiles in Alzheimer's disease relate to cognition and neurodegeneration.

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.

Mona Darwish1, Xiaoshu Feng1, Bryan Dirks1

  • 1Acadia Pharmaceuticals Inc., Princeton, NJ, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
PubMed
Summary
This summary is machine-generated.

This study found that ACP-204 has similar pharmacokinetics and safety profiles in healthy elderly and adult participants. The drug, ACP-204, is being investigated for Alzheimer's disease psychosis (ADP).

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:

  • Pharmacology
  • Geriatric Medicine
  • Neuroscience

Background:

  • Alzheimer's disease psychosis (ADP) affects frail elderly patients vulnerable to antipsychotic side effects.
  • Investigating ACP-204, a 5-HT2A receptor inverse agonist/antagonist, for ADP treatment.
  • Assessing age-related differences in drug pharmacokinetics (PK) and pharmacodynamics is crucial for elderly populations.

Purpose of the Study:

  • To evaluate the pharmacokinetics (PK), safety, and tolerability of ACP-204 in healthy elderly and adult participants.
  • To compare PK parameters at the proposed clinical dose of 60 mg.
  • To determine if age influences ACP-204's drug exposure and safety profile.

Main Methods:

  • Phase 1, double-blind, multiple ascending dose study in healthy adults and elderly.
  • Randomized participants to ACP-204 oral doses up to 60 mg (elderly) and 120 mg (adults).
  • Collected steady-state plasma samples for PK analysis (Cmax-ss, AUCτ), focusing on the 60 mg dose.

Main Results:

  • Elderly participants showed slightly higher Cmax-ss (1.14-fold) and AUCτ (1.20-fold) compared to adults at 60 mg.
  • Mean half-life (t1/2) was comparable: 19.8 hours in elderly vs. 17.8 hours in adults.
  • Safety profiles were similar between elderly and adult groups, with no unexpected findings.

Conclusions:

  • ACP-204 exhibits qualitatively similar PK profiles in healthy elderly and adult participants.
  • Exposure parameters (Cmax,ss and AUCτ) showed minimal differences (14% and 20% higher in elderly, respectively).
  • ACP-204 was generally safe and well-tolerated across all age groups studied.