Phase 2
N=52
Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01300728 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI — 5.87; 8.14; 6.26; 7.08 percent change per participant year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NewGam 10% IVIG (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Sutter Health
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI |
5.87; 8.14; 6.26; 7.08 | — |
| SECONDARY Number of Participants Who Converted From Amnestic Mild Cognitive Impairment (a-MCI) to Alzheimer Disease (AD) |
16; 10 | — |
| SECONDARY Change in Ventricular Volume in Patients With Positive Cerebrospinal Fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer Signature |
294.00; 353.41; 107.47; 96.18; 43.59; 39.47 | — |
| SECONDARY Mean Cognitive Performance at 12 Months |
26.04; 25.38; 11.03; 11.00; 2.7; 2.65 | — |
| SECONDARY Mean Cognitive Performance at 24 Months |
24.00; 24.46; 15.39; 13.25; 4.33; 3.37 | — |
Summary
Patients with mild cognitive impairment (MCI) are a group recognized at being at high risk of progressing to Alzheimer disease. Treatment of MCI with immunotherapy with intravenous immunoglobulins (IVIG) could potentially reduce the risk of progression to Alzheimer disease.
This study will evaluate the efficacy of intravenous immunoglobulin in patients with MCI over 24 months after the first infusion. This study will also document conversion from MCI to Alzheimer's Disease.
Eligibility Criteria
Inclusion Criteria
- Age from 50 to 100 mmHg or systolic BP> 160 mmHg, sitting).
- History or evidence of any clinically significant autoimmune disease or disorder of the immune system (eg., Crohn's Disease, Rheumatoid Arthritis)
- Women of childbearing potential.
- Weight greater than 120 kg (264 lbs).
- Excessive smoking defined as more than 20 cigarettes per day.
- History of alcohol or drug dependence or abuse as defined by DSM-IV criteria within the last 2 years.
- Severe liver or kidney disease verified by the PI review of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine.
- Known coagulopathy, thrombosis, or low platelet count.
- Known deficiency to Immunoglobulin A (IgA).
- Positive serology for Hepatitis B or C, or HIV.
- Concurrent or prior treatment with cholinesterase inhibitors and/or memantine, or Axona for cognitive enhancement. Exceptions (e.g. brief exposure to one of these medications) may be authorized if agreed upon by PI and sub-I.
- Concurrent use of anticholinergic drugs including diphenhydramine.
- Current use of anticonvulsant drugs for seizures, antiparkinson drugs, anticoagulant medications (except the use of aspirin 325 mg/day or less, plavix, aggrenox, and persantine but not for stroke).
- Concurrent use of opioid pain relievers and related synthetic derivatives.
- Use of experimental medications for AD or any other investigational medications or devices within 60 days prior to screening or within 5 half-lives of use of such a medication prior to screening, whichever is longer.
- Prior treatment with IVIG or other experimental immunotherapeutic or vaccine for MCI or AD, or prior treatment with a biological product for the treatment of a-MCI or AD.
Data sourced from ClinicalTrials.gov (NCT01300728). 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.