Alzheimer's Disease Acitretin Medication

A Phase 2 study testing Acitretin in people with Alzheimer Disease, run by K. Lieb at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alzheimer Disease
What is being tested?: Acitretin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 2 sitesGermany
Study dates: Mar 2010to May 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
Universität Rostock
Rostock, 18057

Other trials in Germany

About this study

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

Conditions: Alzheimer Disease
Being tested: Acitretin, Placebo
Keywords: Alzheimer's Disease
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcitretinDrug
Also called Neotigason, Acicutan
30mg per day from Day 1 to Day 28
PlaceboDrug
Placebo

Study groups in NCT01078168
Study group	Role	What they receive
Acitretin	Active comparator	oral, 30 mg per day, day 1-28 Receives: Drug: Acitretin
Placebo	Placebo comparator	oral, day 1-28 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline and 4 weeks (visit 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010May 2013

First posted2 Mar 2010 (estimated)
Study startMar 2010
Primary completionJan 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078168
Sponsor's protocol ID: ADAM
Other IDs: 2009-011881-27, 2009
Acronym: ADAM
Status last verified: Jul 2017
First submitted: 1 Mar 2010
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease
Transcranial Alternating Current Stimulation, Alzheimer Disease (AD)
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging

All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01078168
Acronym / sponsor ID: ADAM / ADAM
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: K. LiebUniversity, hospital or other
Collaborators: Alzheimer Forschungsinitiative e.V. (AFI)
Study start: Mar 2010
Primary completion: Jan 2013 (actual)
Study completion: May 2013 (actual)
First posted: 2 Mar 2010 (estimated)
Results: Posted 5 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Acitretin	Active comparator	Drug: Acitretinoral, 30 mg per day, day 1-28
Placebo	Placebo comparator	Drug: Placebooral, day 1-28

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcitretinAlso: Neotigason, Acicutan30mg per day from Day 1 to Day 28	Drug	Acitretin
PlaceboPlacebo	Drug	Placebo

Primary outcome

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.

Results and safety

Results posted to the registry on 5 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acitretin	11	11
Placebo	11	10

Primary outcome: 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). Mean (Standard Deviation). Unit: fold change (Visit 3/background)

Measure	Acitretin n = 10	Placebo n = 10
Value	1.251 (0.4528)	0.8741 (0.2592)

Acitretin vs Placebo: Mean Difference (Final Values): 0.3769 (95% CI 0.03025 to 0.7235), p = 0.0347, t-test, 2 sided

Population analysed: All patients were included with successful punctation at V1 and V3. For one Acitretin-treated patient not punctation at V3 was obtained (resulting n of 10).

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acitretin	1 of 11 (9.1%)	8 of 11 (72.7%)	Not reported
Placebo	0 of 10 (0%)	5 of 10 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Alzheimer Disease

Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease
Transcranial Alternating Current Stimulation, Alzheimer Disease (AD)
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andreas Fellgiebel, PD Dr. principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acitretin in people with Alzheimer Disease, run by K. Lieb at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.