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| Name | Class |
|---|---|
| Impetus Grants (EIN: 87-1540960) | UNKNOWN |
| The National Association for Public Health, Norway | OTHER_GOV |
| Vestre Viken Hospital Trust | OTHER |
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In the ADDITION-MCI project, patients with a diagnosis of mild cognitive impairment probably caused by Alzheimer's disease will receive plasma exchange.
Repeated plasma exchanges will be conducted, and cognitive outcomes will be measured before and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma exchange | Experimental | 1-20 plasma exchanges. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma exchenge | Biological | Plasma exchange will be conducted. The substitution fluid will be plasma from ha healthy donor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montreal Cognitive Assessment (MoCA) Test for Dementia | Change from baseline to after completion of all procedure cycles | 2 months |
| Change in Montreal Cognitive Assessment (MoCA) Test for Dementia |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DNA methylation age GrimAge2 from baseline | Epigenetic measurement | 6 months |
| 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. |
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0450 | Norway |
We will attempt to share IDP within the European GDPR rules.
Before data analysis and publication
On request to the study contact.
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This is a safety and feasibility study.
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Change from baseline to after the procedure
| 6 months |
| Change in Montreal Cognitive Assessment (MoCA) Test for Dementia | Change from baseline to after the procedure | 12 months |
| Change in Montreal Cognitive Assessment (MoCA) Test for Dementia | Change from baseline to after the procedure | 24 months |
| Change in Montreal Cognitive Assessment (MoCA) Test for Dementia | Change from baseline to after the procedure | 48 months |
| Burden of participation questionnaire sum score | At the end of the procedure | 2 months |
| Change in IL10 from baseline | Change in IL10 | 2 months |
| Change in IL10 from baseline | Change in IL10 | 6 months |
| Change in IL6 from baseline | Change in IL6 | 2 months |
| Change in IL6 from baseline | Change in IL6 | 6 months |
| Change in grip strength from baseline | Change in grip strength from baseline | 2 months |
| Change in grip strength from baseline | Change in grip strength from baseline | 6 months |
| Change in grip strength from baseline | Change in grip strength from baseline | 12 months |
| Change in grip strength from baseline | Change in grip strength from baseline | 24 months |
| Change in grip strength from baseline | Change in grip strength from baseline | 48 months |
| Change in the CERAD 10-word test performance from baseline | Change in the CERAD 10-word test performance from baseline | 2 months |
| Change in the CERAD 10-word test performance from baseline | Change in the CERAD 10-word test performance from baseline | 6 months |
| Change in the CERAD 10-word test performance from baseline | Change in the CERAD 10-word test performance from baseline | 12 months |
| Change in the CERAD 10-word test performance from baseline | Change in the CERAD 10-word test performance from baseline | 24 months |
| Change in the CERAD 10-word test performance from baseline | 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 | Change in the trail making test A or B (as appropriate) time from baseline | 2 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in IQCODE from baseline | Measured at the nearest next-of-kin | 2 months |
| Change in IQCODE from baseline | Measured at the nearest next-of-kin | 6 months |
| Change in IQCODE from baseline | Measured at the nearest next-of-kin | 12 months |
| Change in IQCODE from baseline | Measured at the nearest next-of-kin | 24 months |
| Change in IQCODE from baseline | Measured at the nearest next-of-kin | 48 months |
| Change in 4 meter walk test from baseline | 2 months |
| Change in 4 meter walk test from baseline | 6 months |
| Change in 4 meter walk test from baseline | 12 months |
| Change in 4 meter walk test from baseline | 24 months |
| Change in 4 meter walk test from baseline | 48 months |
| 12 months |
| Single cell RNA seq | 6 months |
| Change in EQ5D | The EQ5D questionnaire will be used | 12 months |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |