Early, mild dementia of the Alzheimer’s Type and therapy-refractory Major Depression MedDRA version: 9.1 Level: LLT Classification code 10012271 Term: Dementia Alzheimer's type MedDRA version: 9.1 Level: LLT Classification code 10066555 Term: Chronic depression
Conditions
Interventions
Trade Name: Erypo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Epoetin alfa
Other descriptive name: Epoetin alfa (6x 0.8ml (8,000 IU))
Concentration unit: IU international unit(s)
Sponsors
Max-Planck-Institute of Experimental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Safety 2) First evidence of efficacy: - Cognitive improvement, outlasting months of an EPO treatment-free period (measured by neuropsychological testing);Secondary Objective: - improvement of affective symptoms (mood) - improvement of quality of life - improvement of global functioning - improvement of activities of daily living - improvement of motor performance - improvement/change of facial/emotional expression - relative increase/reduced decrease in total grey matter measured in defined regions of interest - reduction in biochemical damage markers ;Primary end point(s): 1) Safety: (serious) adverse events, blood parameters, vital signs (especially blood pressure) 2) First evidence of efficacy: - Cognitive functions (measured by neuropsychological testing): global cognitive functioning, speed of processing, attention, visuo-spatial/visuo-constructive functions, executive functions (including working memory), learning and memory - affective symptoms (measured by psychopathological rating scales): depressive symptoms (HAMD), negative, positive and general symptoms (PANSS) | — |
Countries
Germany
Outcome results
None listed