Alzheimer`s Disease Acitretin Medication - Full Text View

Alzheimer`s Disease Acitretin Medication (ADAM)

This study is not yet open for participant recruitment.

Verified by Johannes Gutenberg University Mainz, January 2010

First Received: March 1, 2010 No Changes Posted

Sponsor:	Johannes Gutenberg University Mainz
Collaborator:	Alzheimer Forschungsinitiative e.V. (AFI)
Information provided by:	Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:	NCT01078168

Purpose

The trials investigates the changes of cerebral spinal fluid APPSα levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease.The present study aims to demonstrate an enhancement of the α-secretase activity by acitretin as measured by increased CSF APPSα levels in human AD. Second, the safety and tolerability of acitretin in AD patients should be proven.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Acitretin Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Changes of Cerebral Spinal Fluid APPSα Levels Under Oral Therapy With Acitretin 30 mg Daily in Patients With Mild to Moderate Alzheimer's Disease: a Multicenter Prospective Randomised Placebo-controlled Parallel-group Study

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Acitretin

U.S. FDA Resources

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:

Difference in CSF APPSα concentration at Visit 3 compared to Baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	76
Study Start Date:	March 2010
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

30mg per day from Day 1 to Day 28

Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

mild to moderate AD (NINCDS-ADRDA criteria)
MMSE: 27-14 points
Geriatric Depression Scale ≤ 14

Exclusion Criteria:

hereditary cognitive impairment
known history of brain injuries
Insufficient German language skills
actual treatment with other potential disease modifying drugs of AD
multimorbidity or significant organ (esp. liver or renal) dysfunction
evidence of Non-AD neurodegenerative disorder (e.g. Parkinson)
contraindication to acitretin such as osteoporosis, hypoalbuminaemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078168

Contacts

Contact: Markus Dr. Lorscheider, Clinical coordinator	+49-6131-17-6103	lorscheider@psychiatrie.klinik.uni-mainz.de
Contact: Andreas PD Dr. Fellgiebel, Coordinating investigator	+49-6131-17-2525	fellgiebel@psychiatrie.klinik.uni-mainz.de

Locations

Germany, Rheinland-Pfalz
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz
Mainz, Rheinland-Pfalz, Germany, 55131

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Alzheimer Forschungsinitiative e.V. (AFI)

Investigators

Principal Investigator:

Andreas Fellgiebel, PD Dr.

Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany

More Information

No publications provided

Responsible Party:	University Medical Center of the Johannes Gutenberg-University Mainz; Department of Psychiatrie and Psychotherapy ( PD Dr. Andreas Fellgiebel )
ClinicalTrials.gov Identifier:	NCT01078168 History of Changes
Other Study ID Numbers:	ADAM, 2009-011881-27
Study First Received:	March 1, 2010
Last Updated:	March 1, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:

Alzheimer`s Disease

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Acitretin
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2010