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

Oslo University Hospital1 site in 1 country10 target enrollmentDecember 7, 2023

ConditionsAlzheimer Disease

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Alzheimer Disease
Sponsor: Oslo University Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: Adverse events
Status: Enrolling By Invitation
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 7, 2023

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oslo University Hospital

Responsible Party

Principal Investigator

Arne Vasli Lund Søraas

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Adverse events

Time Frame: 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 Outcomes

Burden of participation questionnaire sum score(2 months)
Change in IL10 from baseline(6 months)
Change in IL6 from baseline(6 months)
Change in Montreal Cognitive Assessment (MoCA) Test for Dementia(48 months)
Change in grip strength from baseline(48 months)
Change in the CERAD 10-word test performance from baseline(48 months)
Change in the trail making test A or B (as appropriate) time from baseline(48 months)
Change in 4 meter walk test from baseline(48 months)
Change in IQCODE from baseline(48 months)