Alzheimer's Disease Acitretin Medication

NCT ID: NCT01078168

Last Updated: 2018-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acitretin

oral, 30 mg per day, day 1-28

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type DRUG

30mg per day from Day 1 to Day 28

Placebo

oral, day 1-28

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Acitretin

30mg per day from Day 1 to Day 28

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Neotigason, Acicutan

Eligibility Criteria

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Inclusion Criteria

* mild to moderate AD (NINCDS-ADRDA criteria)
* Mini-Mental State Examination (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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alzheimer Forschungsinitiative e.V. (AFI)

UNKNOWN

Sponsor Role collaborator

K. Lieb

OTHER

Sponsor Role lead

Responsible Party

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K. Lieb

Herr Univ.-Prof. Dr. med. Andreas Fellgiebel

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andreas Fellgiebel, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Mainz, Rhineland-Palatinate, Germany

Site Status

Universität Rostock

Rostock, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2009-011881-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ADAM

Identifier Type: -

Identifier Source: org_study_id

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