ADAM

CompletedPhase 2Results posted

Alzheimer's Disease Acitretin Medication

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

Lead sponsor

K. Lieb

Asset

Acitretin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 14-27

Primary endpoint

•Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2009-011881-27

Org study IDADAM

NCT IDNCT01078168

Timeline

Milestones

Study start2010-03 (month precision)

Study first posted2010-03-02estimated

Primary completion2013-01actual (month precision)

Study completion2013-05actual (month precision)

Last update posted2018-02-05actual

Results first posted2018-02-05actual

Assets

Drug assets

Acitretin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

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)

concentration, descriptive

Primary/registry result

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)

concentration, descriptive

Posted result

Group	Value (mean), fold change (Visit 3/background)	Standard deviation
Acitretinn=10 Participants	1.251	0.4528
Placebon=10 Participants	0.8741	0.2592

Mean Difference (Final Values)0.376995% CI0.03025 - 0.7235p0.0347t-test, 2 sided

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.