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Alzheimer's Disease Acitretin Medication (ADAM)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Acitretin
Placebo
Sponsored by
K. Lieb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acitretin

Placebo

Arm Description

oral, 30 mg per day, day 1-28

oral, day 1-28

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2010
Last Updated
July 18, 2017
Sponsor
K. Lieb
Collaborators
Alzheimer Forschungsinitiative e.V. (AFI)
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1. Study Identification

Unique Protocol Identification Number
NCT01078168
Brief Title
Alzheimer's Disease Acitretin Medication
Acronym
ADAM
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
K. Lieb
Collaborators
Alzheimer Forschungsinitiative e.V. (AFI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acitretin
Arm Type
Active Comparator
Arm Description
oral, 30 mg per day, day 1-28
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral, day 1-28
Intervention Type
Drug
Intervention Name(s)
Acitretin
Other Intervention Name(s)
Neotigason, Acicutan
Intervention Description
30mg per day from Day 1 to Day 28
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline
Description
Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.
Time Frame
baseline and 4 weeks (visit 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Fellgiebel, PD Dr.
Organizational Affiliation
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universität Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

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Alzheimer's Disease Acitretin Medication

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