Alzheimer's Disease Acitretin Medication

NCT01078168 | Completed Phase 2 Results

• 2 other identifiers: ADAM2009-011881-27
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

The trials investigates the changes of cerebral spinal fluid (CSF) soluble alpha-secretase cleaved APP (APPsα) levels under oral therapy with acitretin 30mg daily in patients with mild to moderate Alzheimer's disease (AD).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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline

  Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.

  baseline and 4 weeks (visit 3)

Study Arms (2)

Acitretin

ACTIVE COMPARATOR

oral, 30 mg per day, day 1-28

Drug: Acitretin

Placebo

PLACEBO COMPARATOR

oral, day 1-28

Drug: Placebo

Interventions

Acitretin DRUG

30mg per day from Day 1 to Day 28

Also known as: Neotigason, Acicutan

Acitretin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to moderate AD (NINCDS-ADRDA criteria)
• Mini-Mental State Examination (MMSE): 27-14 points
• Geriatric Depression Scale ≤ 14

You may not qualify if:

• 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

Sponsors & Collaborators

• K. Lieb: lead
• Alzheimer Forschungsinitiative e.V. (AFI): collaborator

Study Sites (2)

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

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universität Rostock

Rostock, 18057, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Acitretin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Prof. Dr. Andreas Fellgiebel
• Organization: Clinic of Psychiatry and Psychotherapy, University Medical Center JGU Mainz

Andreas.Fellgiebel@unimedizin-mainz.de

+49-6131-17-7363

Study Officials

• Andreas Fellgiebel, PD Dr.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Herr Univ.-Prof. Dr. med. Andreas Fellgiebel

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 5, 2018
• Results First Posted: February 5, 2018

Record last verified: 2017-07

Locations

DE (2)