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

Alzheimer Disease Clinical Trial

— ADDITION-MCI  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06234436
• Other study ID #: 520697
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: December 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

Biological:
• Plasma exchenge
Plasma exchange will be conducted. The substitution fluid will be plasma from ha healthy donor.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Impetus Grants (EIN: 87-1540960), Nasjonalforeningen for folkehelsen, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in DNA methylation age GrimAge2 from baseline	Epigenetic measurement	6 months
Other	Proteomic profile	Comparison of the proteomic profile at baseline and the proteomic profile at 12 months. The profile will be measured using SomaLogic assays and in this endpoint the concentration of each protein at baseline will be compared to the concentration at 12 months.	12 months
Other	Single cell RNA seq		6 months
Other	Change in EQ5D	The EQ5D questionnaire will be used	12 months
Primary	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	Change in Montreal Cognitive Assessment (MoCA) Test for Dementia	Change from baseline to after completion of all procedure cycles	2 months
Secondary	Change in Montreal Cognitive Assessment (MoCA) Test for Dementia	Change from baseline to after the procedure	6 months
Secondary	Change in Montreal Cognitive Assessment (MoCA) Test for Dementia	Change from baseline to after the procedure	12 months
Secondary	Change in Montreal Cognitive Assessment (MoCA) Test for Dementia	Change from baseline to after the procedure	24 months
Secondary	Change in Montreal Cognitive Assessment (MoCA) Test for Dementia	Change from baseline to after the procedure	48 months
Secondary	Burden of participation questionnaire sum score	At the end of the procedure	2 months
Secondary	Change in IL10 from baseline	Change in IL10	2 months
Secondary	Change in IL10 from baseline	Change in IL10	6 months
Secondary	Change in IL6 from baseline	Change in IL6	2 months
Secondary	Change in IL6 from baseline	Change in IL6	6 months
Secondary	Change in grip strength from baseline	Change in grip strength from baseline	2 months
Secondary	Change in grip strength from baseline	Change in grip strength from baseline	6 months
Secondary	Change in grip strength from baseline	Change in grip strength from baseline	12 months
Secondary	Change in grip strength from baseline	Change in grip strength from baseline	24 months
Secondary	Change in grip strength from baseline	Change in grip strength from baseline	48 months
Secondary	Change in the CERAD 10-word test performance from baseline	Change in the CERAD 10-word test performance from baseline	2 months
Secondary	Change in the CERAD 10-word test performance from baseline	Change in the CERAD 10-word test performance from baseline	6 months
Secondary	Change in the CERAD 10-word test performance from baseline	Change in the CERAD 10-word test performance from baseline	12 months
Secondary	Change in the CERAD 10-word test performance from baseline	Change in the CERAD 10-word test performance from baseline	24 months
Secondary	Change in the CERAD 10-word test performance from baseline	Change in the CERAD 10-word test performance from baseline	48 months
Secondary	Change in the trail making test A or B (as appropriate) time from baseline	Change in the trail making test A or B (as appropriate) time from baseline	2 months
Secondary	Change in the trail making test A or B (as appropriate) time from baseline	Change in the trail making test A or B (as appropriate) time from baseline	6 months
Secondary	Change in the trail making test A or B (as appropriate) time from baseline	Change in the trail making test A or B (as appropriate) time from baseline	12 months
Secondary	Change in the trail making test A or B (as appropriate) time from baseline	Change in the trail making test A or B (as appropriate) time from baseline	24 months
Secondary	Change in the trail making test A or B (as appropriate) time from baseline	Change in the trail making test A or B (as appropriate) time from baseline	48 months
Secondary	Change in IQCODE from baseline	Measured at the nearest next-of-kin	2 months
Secondary	Change in IQCODE from baseline	Measured at the nearest next-of-kin	6 months
Secondary	Change in IQCODE from baseline	Measured at the nearest next-of-kin	12 months
Secondary	Change in IQCODE from baseline	Measured at the nearest next-of-kin	24 months
Secondary	Change in IQCODE from baseline	Measured at the nearest next-of-kin	48 months
Secondary	Change in 4 meter walk test from baseline		2 months
Secondary	Change in 4 meter walk test from baseline		6 months
Secondary	Change in 4 meter walk test from baseline		12 months
Secondary	Change in 4 meter walk test from baseline		24 months
Secondary	Change in 4 meter walk test from baseline		48 months