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

University of Oslo (UIO)

Status and phase: Invitation-only; Early Phase 1

Conditions: Alzheimer Disease

Treatments: Biological: Plasma exchenge

Study type: Interventional

Funder types: Other

Identifiers

NCT06234436

520697

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Plasma exchange

Experimental group

Description:

1-20 plasma exchanges.

Treatment:

Biological: Plasma exchenge