Phase 2
Completed N=58
Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00812565 ↗Enrolled (actual)
58
Serious AEs
14.3%
Results posted
May 2014
Primary outcomePrimary: Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion — 161.20; -245.67; -122.50; -39.10 (pg/mL)*days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion |
161.20; -245.67; -122.50; -39.10; 510.92; -83.67 | — |
| SECONDARY Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24) |
27.1; 5.5; -0.3; -6.5; -6.0; -20.3 | — |
| SECONDARY Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24) |
109.7; 74.3; 163.9; 310.2; -56.3; 96.7 | — |
| SECONDARY Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion |
40.70; -8.92; -53.94; -17.00; 50.13; -8.98 | — |
| SECONDARY Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion |
2829.0; 358.3; 1862.5; 2189.6; 196.6; 849.4 | — |
| SECONDARY Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion |
939.4; 266.7; 10.6; -147.0; 42.0; 561.7 | — |
| SECONDARY Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion |
0.38; 0.22; 1.86; -0.78; 0.15; 0.40 | — |
| SECONDARY Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion |
17.4; 209.3; -3.4; -7.8; -33.2; -141.8 | — |
| SECONDARY Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24 |
1.5; -2.3; -0.6; -2.0; -0.7; -1.2 | — |
| SECONDARY Change From Baseline in the Alzheimer's Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24 |
1.11; 0.94; -0.86; -0.07; 1.52; 3.67 | — |
| SECONDARY Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24 |
6.7; 0.0; 1.7; -1.2; -0.6; -8.2 | — |
| SECONDARY Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24 |
-0.67; -0.25; 0.21; 0.60; -0.36; 0.42 | — |
| SECONDARY Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24 |
-0.112; -0.548; -0.709; -1.833; 0.533; -0.528 | — |
| SECONDARY Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24 |
0.83; 0.81; 0.81; 0.83; 0.81; 0.88 | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00812565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.