Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)
- Conditions
- Alzheimer Disease
- Interventions
- Biological: Plasma exchenge
- Registration Number
- NCT06234436
- Lead Sponsor
- Oslo University Hospital
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Plasma exchange Plasma exchenge 1-20 plasma exchanges.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in 4 meter walk test from baseline 48 months Burden of participation questionnaire sum score 2 months At the end of the procedure
Change in IL10 from baseline 6 months Change in IL10
Change in IL6 from baseline 6 months Change in IL6
Change in Montreal Cognitive Assessment (MoCA) Test for Dementia 48 months Change from baseline to after the procedure
Change in grip strength from baseline 48 months Change in grip strength from baseline
Change in the CERAD 10-word test performance from baseline 48 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 48 months Change in the trail making test A or B (as appropriate) time from baseline
Change in IQCODE from baseline 48 months Measured at the nearest next-of-kin
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway