Status:
COMPLETED
Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Octapharma
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin \[IVIG\]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF...
Detailed Description
Participants received 12 infusions of 0.1 g/kg, 0.25 g/kg, or 0.4 g/kg body weight octagam 10% at 2-week intervals (±3 days) or 6 infusions of 0.2 g/kg, 0.5 g/kg, or 0.8 g/kg body weight octagam 10% a...
Eligibility Criteria
Inclusion
- Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Age of 50 to 85.
- Mini-mental State Examination (MMSE) score of 16 to 26.
- Sufficient language skills for testing.
- Sufficient vision and hearing for testing.
- Modified Hachinski-Rosen Score \< 5.
- Magnetic resonance imaging (MRI) of the head consistent with the diagnosis of AD.
- Caregiver available with contact at least 4 days per week for greater than 1 hour.
- Outpatient status or assisted living.
- 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 (eg, acetylcholine esterase (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 electrocardiogram (ECG) or clinically not significant, if outside normal limits.
Exclusion
- Other causes of dementia (eg, vascular dementia, Lewy-body dementia, fronto-temporal dementia, Creutzfeldt-Jacob disease, Huntington's disease, Parkinson's disease).
- History of or present significant other diseases of the central nervous system (eg, brain tumor, normal pressure hydrocephalus, Parkinson's Disease, stroke, severe brain trauma, brain surgery, epilepsy, encephalitis).
- Geriatric depression scale score \> 7 (short form with scale from 0 to 15).
- Present significant psychiatric disorder (eg, 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 unless on stable replacement therapy for at least 3 months is acceptable.
- Unstable thyroid dysfunction.
- Uncontrolled hypertension.
- Severe liver or kidney disease.
- Major surgery within 3 months prior to screening.
- Prohibited medications: Antiepileptic drugs, antipsychotics (but allowed for treatment of acute episodes), antiparkinson agents, anticholinergic drugs, selegiline, monoamine oxidase inhibitors (MAOI), tricyclics, immunosuppressive medications, anti-histamines (unless on a stable dose for at least 3 months or used for treatment of acute episodes), benzodiazepines (but allowed for treatment of acute episodes), and lithium.
- Antidepressants are permitted, if on a stable dose for at least 3 months and without significant anticholinergic side-effects.
- Peripheral venous conditions which impair establishing regular venous access for infusions.
- Potential reasons that patient may become non-evaluable during the study (eg, 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 (eg, 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 another drug trial within the previous 3 months before screening.
- Participation in immunological treatment studies of AD other than with intravenous immunoglobulin (IGIV) within the previous 6 months before screening.
- IGIV use in the previous 6 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00812565
Start Date
February 1 2009
End Date
September 1 2010
Last Update
May 5 2014
Active Locations (1)
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1
Octapharma USA
Hoboken, New Jersey, United States