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

Sponsor
German Center for Neurodegenerative Diseases (DZNE)
Study ID
NCT03056495
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 28, 2017
Status verified
Jul 2019
Primary completion
Mar 4, 2024
Completion
Mar 4, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Investigational drug
    N-hydroxy-N'-phenyl-octanediamide (Vorinostat) capsules once a day, three weeks of treatment; dose escalation with different dosages per cohort; One cohort of three subjects

Primary Outcome Measure

Determination of the maximum-tolerated dose (MTD) in elderly subjects during dose escalation [ Time Frame: 12 months ]

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