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

NCT06234436 | Unknown Early Phase 1

• 1 other identifier: 520697
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 years

Secondary Outcomes (35)

• Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

  2 months

• Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

  6 months

• Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

  12 months

• Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

  24 months

• Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

  48 months

Other Outcomes (4)

• Change in DNA methylation age GrimAge2 from baseline

  6 months

• Proteomic profile

  12 months

• Single cell RNA seq

  6 months

Study Arms (1)

Plasma exchange

EXPERIMENTAL

1-20 plasma exchanges.

Biological: Plasma exchenge

Interventions

Plasma exchenge BIOLOGICAL

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

Plasma exchange

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Impetus Grants (EIN: 87-1540960): collaborator
• The National Association for Public Health, Norway: collaborator
• Vestre Viken Hospital Trust: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: This is a safety and feasibility study.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 31, 2024
• Study Start: December 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Before data analysis and publication
• Access Criteria: On request to the study contact.

Locations

NO (1)