Alzheimer's Disease Acitretin Medication

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acitretin

Drug

30mg per day from Day 1 to Day 28

Other names: Neotigason, Acicutan

Placebo

Drug

Placebo

Primary outcomes

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

Time frame: baseline and 4 weeks (visit 3)

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

Sponsors and collaborators

Lead sponsor

K. Lieb

Other

Collaborators

Alzheimer Forschungsinitiative e.V. (AFI)

Registry information

Official study 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

Acronym: ADAM

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Mar 2, 2010
Registry last updated: Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed