DIMAP: Disulfiram as a Modulator of Amyloid Precursor Protein-processing

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Completed

CT.gov ID

NCT03212599

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Alcohol Addiction	Drug: Disulfiram

Study Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jul 1, 2017

Outcome Measures

Primary Outcome Measures

expression of ADAM10 [August 2016]
expression of ADAM10 in the collected blood samples measured by quantitation of the mRNA amount using RealTime-RT-PCR.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Investigators

Principal Investigator: Kristina Endres, Medical Center Johannes Gutenberg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

K. Lieb, Director, Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier:

NCT03212599

Other Study ID Numbers:

DIMAP

First Posted:

Jul 11, 2017

Last Update Posted:

Jul 24, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by K. Lieb, Director, Johannes Gutenberg University Mainz

Additional relevant MeSH terms:

Alcoholism

Disulfiram

Study Results

No Results Posted as of Jul 24, 2017