Alzheimer's Disease Acitretin Medication (ADAM)

K. Lieb

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Acitretin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01078168

ADAM

2009-011881-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Acitretin

Active Comparator group

Description:

oral, 30 mg per day, day 1-28

Treatment:

Drug: Acitretin

Placebo

Placebo Comparator group

Description:

oral, day 1-28

Treatment:

Drug: Placebo