Phase 2 N=22 Randomized Double-blind Treatment

Alzheimer's Disease Acitretin Medication

Alzheimer Disease

Bottom Line

View on ClinicalTrials.gov: NCT01078168 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Feb 2018

Primary outcome: Primary: Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline — 1.251; 0.8741 fold change (Visit 3/background) — p=0.0347

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acitretin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: K. Lieb
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline	1.251; 0.8741	0.0347 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01078168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.