Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment (NCT01300728) | Clinical Trial Compass
CompletedPhase 2
Study of Intravenous Immunoglobulin in Amnestic Mild Cognitive Impairment
United States52 participantsStarted 2011-01-01
Plain-language 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.
Who can participate
Age range50 Years – 84 Years
SexALL
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Inclusion criteria
✓. Age from 50 to \< 85 years old.
✓. Diagnosis of Mild Cognitive Impairment, Amnestic type (single or multi domain) according to Petersen criteria (Appendix B) and supported by a CDR score of 0.5.
✓. Mini-Mental State Examination (MMSE) score of 24-30, inclusive.
✓. Willing to consent to Apolipoprotein E (ApoE) testing and agree to disclose Apolipoprotein E4 (ApoE4) status. Previous ApoE testing will be accepted.
✓. Receiving stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to screening.
✓. Ability to attend all clinical visits and have an informant capable of accompanying the subject on specific clinic visits for two years or the duration of the study.
✓. The subject's collaborative informant (support person) must be someone who has known the subject for at least 4 years; agrees to have at least 2 separate communications with the study participant per month for the duration of the study (one of these communications must be in person); and attends and completes the CDR interview at 8 study visits along with the subject.
Exclusion criteria
✕. Has significant neurological disease, other than a-MCI that may affect cognition.
✕. History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque.
What they're measuring
1
Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI
Timeframe: Baseline, 12, and 24 month MRI evaluation
✕. History of seizures, excluding febrile seizures in childhood.
✕. Brain MRI shows moderate or severe cortical or hippocampal atrophy.
✕. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, CSF shunts, claustrophobia, metal fragments or foreign objects in the eyes, skin, or body that would contraindicate a brain MRI scan.
✕. Current presence of a clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR).
✕. History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma, and squamous cell carcinoma of the skin.