Disulfiram as a Modulator of Amyloid Precursor Protein-processing

NCT03212599 | Completed

• 1 other identifier: DIMAP
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

Brief Summary

A causal therapeutic approach for treatment of Alzheimer's disease has not been established so far. The protein ADAM10 represents a promising target for an A-beta peptide preventing strategy. Treatment of human neuronal cells with Disulfiram, a drug which is used in clinical routine for recrudescence prevention of alcohol dependency, revealed an increased expression of ADAM10. This finding indicates a neuroprotective potential of Disulfiram. The investigators' research purpose aims at the verification of the results obtained in cell culture experiments in the human organism. Therefore, include alcohol addicted patients were included, which take the drug Disulfiram for recrudescence prevention, in our study. Patients are recruited from the patient-collective of the University Medical Center Mainz and the Central Institute for Mental Health Mannheim. Blood samples (max. 5 ml) are taken from the participants before the intake of Disulfiram and about two weeks after treatment. Demographic data are collected (such as age or onset of addiction). Gene expression is analyzed via reverse transcription polymerase chain reaction(RT-PCR) from blood cell-derived messenger ribonucleic acid (mRNA).

Conditions

Alcohol Addiction

Keywords

APP-processing; Disulfiram; ADAM10; Alzheimer's disease; blood

Outcome Measures

Primary Outcomes (1)

• expression of ADAM10

  expression of ADAM10 in the collected blood samples measured by quantitation of the mRNA amount using RealTime-RT-PCR.

  August 2016

Interventions

Disulfiram DRUG

alcohol addicted patients receive an oral Disulfiram application as recrudescence prevention after successful detoxication

Also known as: Antabus

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Recruited are alhohol addicted patients, which take Disulfiram as recrudescence prevention after successful detoxication. Patients between 20 and 60 years of age are included in the study independent from gender or ethnic background

You may qualify if:

• ambulant or stationary patients, which receive Disulfiram for recrudescence prevention

You may not qualify if:

• Diagnosed Alzheimer's dementia Previous Disulfiram treatment less than four weeks before baseline blood collection

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Related Publications (1)

• Saifi MA, Shaikh AS, Kaki VR, Godugu C. Disulfiram prevents collagen crosslinking and inhibits renal fibrosis by inhibiting lysyl oxidase enzymes. J Cell Physiol. 2022 May;237(5):2516-2527. doi: 10.1002/jcp.30717. Epub 2022 Mar 13.

  PMID: 35285015 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples of each participant are retained and stored at -80.

MeSH Terms

Conditions

Alcoholism; Alzheimer Disease 10; Alzheimer Disease

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• Kristina Endres

  Medical Center Johannes Gutenberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: May 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be published in 2017/18. Availabilty will depend on the Chosen Journal.