Open-label phase IIa pilot study exploring safety and potential efficacy of recombinant human erythropoietin in early mild Alzheimer Dementia and therapy-refractory Major Depression (EPO-AD”) - EPO-AD

Active, not recruiting

Conditions: Early, mild dementia of the Alzheimer’s Type and therapy-refractory Major Depression
MedDRA version: 9.1Level: LLTClassification code 10012271Term: Dementia Alzheimer's type
MedDRA version: 9.1Level: LLTClassification code 10066555Term: Chronic depression

Registration Number: EUCTR2008-000453-35-DE

Lead Sponsor: Max-Planck-Institute of Experimental Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 20

Inclusion Criteria

For patients with Alzeimer's Dementia:
- Diagnosis of a dementia of the Alzheimer’s Type (DSM-IV)
with an initial MMST score 20-26
- Age >40 to 70 years
- Close relative(s) available
For patients with Major Depression:
- Diagnosis of recurrent Major Depression (DSM-IV) with an initial HAMD score = 18
- Age >18 to 70 years
- no or inadequate response to two or more adequate trials of different classes of
conventional antidepressants, each tried for at least 2-3 months (i.e. therapy-
refractory MD)
General eligibility criteria for both patient groups:
- Both genders
- Outpatients
- Written informed consent, full contractual capability, authorization of release and
use of protected health information
- Stable medication for at least 4 weeks prior to inclusion and during follow-up
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Diagnosis of dementia due to (other) medical conditions
(in patients with Major Depression: previous diagnosis of any dementia)
- Diagnosis of psychotic, bipolar or post-traumatic stress disorders
- Dependence on or abuse of drugs (including benzodiazepines and alcohol)
- Acute suicidal tendencies
- Diagnosis of a neurological or other severe disease (e.g. myeloproliferative
disorder, malignancies, polycythemia)
- Renal failure (i.e. dialysis-dependent)
- Prior EPO treatment
- Major surgery within 4 weeks prior to inclusion
- Increased thrombembolic risk
- Smoking
- Continuous medication of sex hormones/contraceptives
- Initial hematocrit >50% (males) or >48% (females)
- Untreated or not sufficiently treated arterial hypertension
- MRI contraindications
- Known allergy or antibodies against erythropoietin