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Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

NCT01467726•Alfasigma S.p.A.

View on ClinicalTrials.gov

Summary

This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.

Eligibility

Age

65 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Is in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (PE), vital signs (VS) (including blood pressure and pulse rate measurement), 12-lead ECG, and clinical laboratory tests.
•Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non-insulin dependent diabetes, osteoarthritis) may be enrolled if well controlled and not anticipated to interfere with the objectives of the study.
•Mild deviations from normal limits in PE, VS, ECG parameters, lab tests are acceptable if associated with the stable condition or are age-related

Exclusion Criteria

•Has a condition, which in the opinion of the investigator, would confound or interfere with evaluation of safety and tolerability or PK or PD of the investigational drug, or prevent compliance with the protocol

Locations (1)

Comprehensive Clinical Development

Miramar, Florida, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

January 1, 2012

Completion Date

January 1, 2012

Last Updated

July 8, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

Velusetrag

DRUG

Velusetrag

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

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Alzheimer's Disease Psychosis

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RECRUITING

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NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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