Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)

Early Phase 1UnknownNCT06234436

Oslo University Hospital10 enrolled

Overview

In the ADDITION-MCI project, patients with a diagnosis of mild cognitive impairment probably caused by Alzheimer's disease will receive plasma exchange.

Repeated plasma exchanges will be conducted, and cognitive outcomes will be measured before and after the intervention.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

Plasma exchengeBIOLOGICAL

Plasma exchange will be conducted. The substitution fluid will be plasma from ha healthy donor.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Adverse events

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.

Time frame: Up to 4 years