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Clinical Trial to Determine Tolerable Dosis of Vorinostat in Patients With Mild Alzheimer Disease

NCT03056495 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-04-10

No results posted yet for this study

Summary

This Clinical Trial is an open, non-randomized Phase Ib study to determine the maximal tolerable dose (MTD) of Vorinostat in Alzheimer disease (AD) patients between (including) 55 and 90 years with mild symptoms. The MTD in this study is defined as the dose that leads to maximum toxicity with Common Toxicity Criteria (CTC) grade 1 symptoms.The safety and tolerability of Vorinostat in this group of study participants should be tested.

Conditions

  • Alzheimer Disease

Interventions

DRUG

N-hydroxy-N'-phenyl-octanediamide (Vorinostat)

N-hydroxy-N'-phenyl-octanediamide capsules once a day, three weeks of treatment; dose escalation with different dosages per cohort; One cohort of three subjects

Sponsors & Collaborators

  • University Hospital, Bonn

    collaborator OTHER

  • University of Göttingen

    collaborator OTHER

  • German Center for Neurodegenerative Diseases (DZNE)

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2024-03-04
Completion
2024-03-04
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056495 on ClinicalTrials.gov