Result card

  • EFF4a: Are IVIG effective in improving cognitive functions of patients with Mild Cognitive Impairment when compared to placebo?
  • EFF4b: Are IVIG effective in improving cognitive functions of patients with mild-to-moderate Alzheimer’s disease when compared to placebo or acetyl cholinesterase inhibitors? Jump to
  • EFF4c: Are IVIG effective in improving cognitive functions of patients with moderate-to-severe Alzheimer’s disease when compared to placebo or memantine? Jump to
English

Are IVIG effective in improving cognitive functions of patients with Mild Cognitive Impairment when compared to placebo?

Authors: Luca Vignatelli, Luciana Ballini, Susanna Maltoni, Jelena Barbaric, Mirjana Huic, Pernilla Östlund.

Internal reviewers: Gerardo Atienza, Agnes Mannik

The same methodology was used as described in section for the whole domain.

No evidence is available on effectiveness of IVIG for patients with MCI.

Vignatelli L et al. Result Card EFF4a In: Vignatelli L et al. Clinical Effectiveness In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 24 October 2020]. Available from: http://corehta.info/ViewCover.aspx?id=267

Are IVIG effective in improving cognitive functions of patients with mild-to-moderate Alzheimer’s disease when compared to placebo or acetyl cholinesterase inhibitors?

Authors: Luca Vignatelli, Luciana Ballini, Susanna Maltoni, Jelena Barbaric, Mirjana Huic, Pernilla Östlund.

Internal reviewers: Gerardo Atienza, Agnes Mannik

The same methodology was used as described in section for the whole domain.

Data on cognitive function changes, measured by ADAS-Cog (co-primary outcome) and ADCSC-GIC, were available from 300 and 298 patients respectively (out of 383) of one RCT {NCT00818662}. See Appendix 2 for detailed results.

Mean score change from baseline at 18 months in the ADAS-Cog did not differ between IVIG 400 mg/kg group (105 patients) and placebo group (95 patients) (-0.8 point score of difference, 95%CI -3.1 to 1.5; P = 0.476) and between IVIG 200 mg/kg group (100 patients) and placebo group (95 patients) (0.7 point score of difference, 95%CI -1.6 to 3.0; P = 0.530). Accordingly mean score change from baseline at 9 months in the ADAS-Cog did not differ between IVIG 400 mg/kg group and placebo group and between IVIG 200 mg/kg group and placebo group.

Difference in means from baseline at 18 months in the ADCSC-GIC did not differ between IVIG 400 mg/kg group (105 patients) and placebo group (92 patients) (Difference in least square means: -0.1, 95% CI -0.3 to 0.2; P = 0.660) and between IVIG 200 mg/kg group (101 patients) and placebo group (92 patients) (0.0, 95% CI -0.2 to 0.3 ; P = 0.766). Accordingly mean score change from baseline at 9 months in the ADCSC-GIC did not differ between IVIG 400 mg/kg group and placebo group and between IVIG 200 mg/kg group and placebo group. See Appendix 2 for details.

Table 3. Summary of findings: cognitive function changes in patients with mild-to-moderate AD treated with IVIG

Cognitive functions: ADAS-Cog mean score change from baseline to 18 months

-0.8 (95% CI -3.1 to 1.5 ); P = 0.476

0.7 (95% CI -1.6 to 3.0)*; P = 0.530

Very low

Cognitive functions: ADCSC-GIC change from baseline to 18 months

-0.1 (95% CI -0.3 to 0.2); P = 0.660

0.0 (95% CI -0.2 to 0.3 ); P = 0.766

Very low

 

Critical
Completely
Vignatelli L et al. Result Card EFF4b In: Vignatelli L et al. Clinical Effectiveness In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 24 October 2020]. Available from: http://corehta.info/ViewCover.aspx?id=267

Are IVIG effective in improving cognitive functions of patients with moderate-to-severe Alzheimer’s disease when compared to placebo or memantine?

Authors: Luca Vignatelli, Luciana Ballini, Susanna Maltoni, Jelena Barbaric, Mirjana Huic, Pernilla Östlund.

Internal reviewers: Gerardo Atienza, Agnes Mannik

The same methodology was used as described in section for the whole domain.

No evidence is available on effectiveness of IVIG for patients with moderate-to-severe AD.

Critical
Completely
Vignatelli L et al. Result Card EFF4c In: Vignatelli L et al. Clinical Effectiveness In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 24 October 2020]. Available from: http://corehta.info/ViewCover.aspx?id=267

References