Prospective 24-week, double-blind, randomized, placebo-controlled, multicenter study evaluating safety and change in efficacy-related surrogate parameters in patients with dementia of the Alzheimer’s type under treatment with increasing dosages of intravenous immunoglobulin (octagam® 10%)
- Conditions
- mild to moderate Alzheimer´s disease
- Registration Number
- EUCTR2007-007134-19-DE
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 56
·Probable AD according to NINCDS-ADRDA criteria.
·Written informed consent by patient or, for significantly cognitively impaired individuals, their legally authorized representative.
·Age: >=50 and <=85.
·MMSE: >=16 and <=26.
·Only for Germany: The patient’s capacity to consent has to be confirmed by dated signature on the informed consent form by a second independent investigator who is otherwise not involved in study GAM10-04 prior to any study-related examinations.
·Sufficient language skills for testing.
·Sufficient vision and hearing for testing.
·Modified Hachinski-Rosen Score < 5.
·MRI of the head consistent with the diagnosis of AD
·Caregiver with contact at least 4 days per week for >= 1 hour available.
·Outpatient status (includes Betreutes Wohnen” in Germany) or assisted living in US.
·Post-menopause (women) as evidenced by lack of menstruation for at least 12 consecutive months or by having bilateral oophorectomy.
·Stable doses of approved AD medication(s) for at least 3 months prior to screening (e.g. AChE inhibitors, memantine)
·Normal vital signs or clinically insignificant, if outside normal limits.
·Laboratory findings within normal limits or clinically insignificant, if outside normal limits.
·Normal ECG or clinically not significant, if outside normal limits.
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
·Other causes of dementia (e.g. vascular dementia, Lewy Body dementia, fronto-temporal dementia, Creutzfeld-Jacob disease, Huntington’s disease, Parkinson’s disease).
·History of or present significant other diseases of the central nervous system (e.g. brain tumor, normal pressure hydrocephalus, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis).
·Geriatric depression scale of > 7 (short form with scale from 0 to 15).
·Present significant psychiatric disorder (e.g. major depression).
·History of psychosis or hallucinations.
·Mental retardation.
·Unstable medical disease in the opinion of the investigator
·Insulin dependent diabetes mellitus.
·Acute infectious disease.
·Vitamin B12 deficiency, though on stable replacement therapy for >= 3 months is acceptable.
·Unstable thyroid dysfunction, stable treated hypothyroidism for >= 3 months is acceptable, but not hyperthyroidism
·Uncontrolled hypertension (diastolic BP> 90 mmHg or systolic BP> 160 mmHg; sitting).
·Severe liver or kidney disease (ALAT > 3x upper limit of normal, creatinine > 120 µmol/L).
·Major surgery within three months prior to screening (e.g. heart surgery, hip replacement).
·Prohibited medications: antiepileptic drugs, antipsychotics, antiparkinson agents, anticholinergic drugs, selegiline, MAOI, tricyclics, immunosuppressive medications, anti-histamines (unless on a stable dose for at least 3 months), benzodiazepines, and Lithium
·Antidepressants are not permitted, unless if on stable dose for at least 3 months and without significant anticholinergic side-effects
·Potential reasons that patient may become non-evaluable during the study (e.g. planned moving into a nursing home, but assisted living is acceptable).
·Peripheral venous conditions, which impair establishing regular venous access for infusions
·Known IgA deficiency with antibodies to IgA.
·History of hypersensitivity to blood or plasma derived products, or any component of octagam® 10%, such as maltose.
·Medical conditions, which interfere with protein catabolism (e.g. nephrotic syndrome).
·Known blood hyperviscosity, or other hypercoagulable states.
·Deep vein thrombosis within preceding 4 years
·Symptomatic stroke
·Transient ischemic attack (TIA) within preceding 2 years
·Participation in other drug trial currently or within the previous 3 months before screening.
·Participation in immunological treatment studies of AD other than with IGIV within the previous 6 months before screening.
·IGIV use in the previous six months.
·Live viral vaccination within the last month before study entry.
·Not eligible for lumbar puncture (anticoagulant therapy, coagulation disorders, severe spinal alterations).
·Patients with a past or present history of drug abuse or alcohol abuse within the preceding 5 years.
·Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method