Clinical trial NCT06234436: Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)
Official title: Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Impetus Grants (EIN: 87-1540960)
name: The National Association for Public Health, Norway
name: Vestre Viken Hospital Trust
First posted: 2024-01-31
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a safety and feasibility study.
Primary purpose: TREATMENT

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.

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

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.

Primary outcomes:
measure: Adverse events
timeFrame: Up to 4 years
Secondary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA) Test for Dementia
timeFrame: 2 months
measure: Change in Montreal Cognitive Assessment (MoCA) Test for Dementia
timeFrame: 6 months
measure: Change in Montreal Cognitive Assessment (MoCA) Test for Dementia
timeFrame: 12 months
measure: Change in Montreal Cognitive Assessment (MoCA) Test for Dementia
timeFrame: 24 months
measure: Change in Montreal Cognitive Assessment (MoCA) Test for Dementia
timeFrame: 48 months
measure: Burden of participation questionnaire sum score
timeFrame: 2 months
measure: Change in IL10 from baseline
timeFrame: 2 months
measure: Change in IL10 from baseline
timeFrame: 6 months
measure: Change in IL6 from baseline
timeFrame: 2 months
measure: Change in IL6 from baseline
timeFrame: 6 months
measure: Change in grip strength from baseline
timeFrame: 2 months
measure: Change in grip strength from baseline
timeFrame: 6 months
measure: Change in grip strength from baseline
timeFrame: 12 months
measure: Change in grip strength from baseline
timeFrame: 24 months
measure: Change in grip strength from baseline
timeFrame: 48 months
measure: Change in the CERAD 10-word test performance from baseline
timeFrame: 2 months
measure: Change in the CERAD 10-word test performance from baseline
timeFrame: 6 months
measure: Change in the CERAD 10-word test performance from baseline
timeFrame: 12 months
measure: Change in the CERAD 10-word test performance from baseline
timeFrame: 24 months
measure: Change in the CERAD 10-word test performance from baseline
timeFrame: 48 months
measure: Change in the trail making test A or B (as appropriate) time from baseline
timeFrame: 2 months
measure: Change in the trail making test A or B (as appropriate) time from baseline
timeFrame: 6 months
measure: Change in the trail making test A or B (as appropriate) time from baseline
timeFrame: 12 months
measure: Change in the trail making test A or B (as appropriate) time from baseline
timeFrame: 24 months
measure: Change in the trail making test A or B (as appropriate) time from baseline
timeFrame: 48 months
measure: Change in IQCODE from baseline
timeFrame: 2 months
measure: Change in IQCODE from baseline
timeFrame: 6 months
measure: Change in IQCODE from baseline
timeFrame: 12 months
measure: Change in IQCODE from baseline
timeFrame: 24 months
measure: Change in IQCODE from baseline
timeFrame: 48 months
measure: Change in 4 meter walk test from baseline
timeFrame: 2 months
measure: Change in 4 meter walk test from baseline
timeFrame: 6 months
measure: Change in 4 meter walk test from baseline
timeFrame: 12 months
measure: Change in 4 meter walk test from baseline
timeFrame: 24 months
measure: Change in 4 meter walk test from baseline
timeFrame: 48 months
Other outcomes:
measure: Change in DNA methylation age GrimAge2 from baseline
timeFrame: 6 months
measure: Proteomic profile
timeFrame: 12 months
measure: Single cell RNA seq
timeFrame: 6 months
measure: Change in EQ5D
timeFrame: 12 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: