Alzheimer Disease
Conditions
Brief summary
In the ADDITION-MCI project, patients with a diagnosis of mild cognitive impairment probably caused by Alzheimer's disease will receive plasma exchange.
Detailed description
Repeated plasma exchanges will be conducted, and cognitive outcomes will be measured before and after the intervention.
Interventions
BIOLOGICALPlasma exchenge
Plasma exchange will be conducted. The substitution fluid will be plasma from ha healthy donor.
Sponsors
Impetus Grants (EIN: 87-1540960)
The National Association for Public Health, Norway
Vestre Viken Hospital Trust
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a safety and feasibility study.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of Alzheimer's Disease MoCA score \< 27 and \>17 Able to give informed consent as judged by the doctor setting the AD diagnosis and study doctor. At least one biomarker of the AT(N)-classification system supporting the diagnosis Expected to live more than five years at inclusion by the study doctor.
Exclusion criteria
Known IgA deficiency Known severe protein S depletion Previous severe allergic reaction after transfusion of a blood product Known heart failure Known liver failure Known kidney failure Previous cancer \<10 years. Not deemed able to participate by the study staff Other severe chronic diseases, interfering with the TPE-procedure Ongoing infections Other unresolved medical conditions Known coagulopathies Fulfilling ICD-10 criteria for dementia at baseline, as evaluated by the evaluating physician. Peripheral veins not expected to be suitable for repeated venous access procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 4 years | Safety of the intervention in the patient group measured as number and severity of adverse events. This will be evaluated as the number of participants with treatment-related adverse events as assessed by CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IL6 from baseline | 2 months | Change in IL6 |
| Change in the CERAD 10-word test performance from baseline | 2 months | Change in the CERAD 10-word test performance from baseline |
| Change in the trail making test A or B (as appropriate) time from baseline | 2 months | Change in the trail making test A or B (as appropriate) time from baseline |
| Change in IQCODE from baseline | 2 months | Measured at the nearest next-of-kin |
| Change in 4 meter walk test from baseline | 2 months | — |
| Change in Montreal Cognitive Assessment (MoCA) Test for Dementia | 2 months | Change from baseline to after completion of all procedure cycles |
| Burden of participation questionnaire sum score | 2 months | At the end of the procedure |
| Change in IL10 from baseline | 2 months | Change in IL10 |
| Change in grip strength from baseline | 2 months | Change in grip strength from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Single cell RNA seq | 6 months | — |
| Change in EQ5D | 12 months | The EQ5D questionnaire will be used |
| Proteomic profile | 12 months | Comparison of the proteomic profile at baseline and the proteomic profile at 12 months. The profile will be measured using SomaLogic assays and in this endpoint the concentration of each protein at baseline will be compared to the concentration at 12 months. |
| Change in DNA methylation age GrimAge2 from baseline | 6 months | Epigenetic measurement |
Countries
Norway
Outcome results
None listed