Disulfiram as a Modulator of Amyloid Precursor Protein-processing

Alcohol Addiction Clinical Trial

— DIMAP  

Official title:

Quantitative Analysis of the Expression of Dementia-relevant Genes by Intake of the Drug Disulfiram

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212599
• Other study ID #: DIMAP
• Status: Completed
• Phase: N/A
• First received: July 6, 2017
• Last updated: July 20, 2017
• Start date: May 2013
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

ambulant or stationary patients, which receive Disulfiram for recrudescence prevention

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Alcohol Addiction
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expression of ADAM10	expression of ADAM10 in the collected blood samples measured by quantitation of the mRNA amount using RealTime-RT-PCR.	August 2016