Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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) and on the increase of Aβ in blood plasma in patients with mild to moderate Alzheimer's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octapharma
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.