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Alzheimer DiseaseEarly Phase 1ADDITION-MCINCT06234436

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

A Early Phase 1 study testing Plasma exchenge in people with Alzheimer Disease, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Alzheimer Disease
What is being tested?
Plasma exchenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNorway
Study dates
7 Dec 2023to 31 Dec 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo, 0450

Other trials in Norway

About this study

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

Read the detailed description

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

Being tested
Plasma exchenge
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plasma exchengeBiological

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

Study groups in NCT06234436
Study groupRoleWhat they receive
Plasma exchangeExperimental1-20 plasma exchanges.
Receives: Biological: Plasma exchenge

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 4 years

Secondary outcomes (35)

  1. Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

    Change from baseline to after completion of all procedure cycles

    Measured: 2 months

  2. Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

    Change from baseline to after the procedure

    Measured: 6 months

  3. Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

    Change from baseline to after the procedure

    Measured: 12 months

  4. Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

    Change from baseline to after the procedure

    Measured: 24 months

  5. Change in Montreal Cognitive Assessment (MoCA) Test for Dementia

    Change from baseline to after the procedure

    Measured: 48 months

  6. Burden of participation questionnaire sum score

    At the end of the procedure

    Measured: 2 months

  7. Change in IL10 from baseline

    Change in IL10

    Measured: 2 months

  8. Change in IL10 from baseline

    Change in IL10

    Measured: 6 months

  9. Change in IL6 from baseline

    Change in IL6

    Measured: 2 months

  10. Change in IL6 from baseline

    Change in IL6

    Measured: 6 months

  11. Change in grip strength from baseline

    Change in grip strength from baseline

    Measured: 2 months

  12. Change in grip strength from baseline

    Change in grip strength from baseline

    Measured: 6 months

  13. Change in grip strength from baseline

    Change in grip strength from baseline

    Measured: 12 months

  14. Change in grip strength from baseline

    Change in grip strength from baseline

    Measured: 24 months

  15. Change in grip strength from baseline

    Change in grip strength from baseline

    Measured: 48 months

  16. Change in the CERAD 10-word test performance from baseline

    Change in the CERAD 10-word test performance from baseline

    Measured: 2 months

  17. Change in the CERAD 10-word test performance from baseline

    Change in the CERAD 10-word test performance from baseline

    Measured: 6 months

  18. Change in the CERAD 10-word test performance from baseline

    Change in the CERAD 10-word test performance from baseline

    Measured: 12 months

  19. Change in the CERAD 10-word test performance from baseline

    Change in the CERAD 10-word test performance from baseline

    Measured: 24 months

  20. Change in the CERAD 10-word test performance from baseline

    Change in the CERAD 10-word test performance from baseline

    Measured: 48 months

  21. 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

    Measured: 2 months

  22. 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

    Measured: 6 months

  23. 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

    Measured: 12 months

  24. 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

    Measured: 24 months

  25. 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

    Measured: 48 months

  26. Change in IQCODE from baseline

    Measured at the nearest next-of-kin

    Measured: 2 months

  27. Change in IQCODE from baseline

    Measured at the nearest next-of-kin

    Measured: 6 months

  28. Change in IQCODE from baseline

    Measured at the nearest next-of-kin

    Measured: 12 months

  29. Change in IQCODE from baseline

    Measured at the nearest next-of-kin

    Measured: 24 months

  30. Change in IQCODE from baseline

    Measured at the nearest next-of-kin

    Measured: 48 months

  31. Change in 4 meter walk test from baseline

    Measured: 2 months

  32. Change in 4 meter walk test from baseline

    Measured: 6 months

  33. Change in 4 meter walk test from baseline

    Measured: 12 months

  34. Change in 4 meter walk test from baseline

    Measured: 24 months

  35. Change in 4 meter walk test from baseline

    Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start7 Dec 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a safety and feasibility study.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06234436
Sponsor's protocol ID
520697
Acronym
ADDITION-MCI
Status last verified
Jan 2024
First submitted
22 Dec 2023
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will attempt to share IDP within the European GDPR rules.

Publications

  • Soraas A, Engvig A, Alnaes D, Karim LN, Danilova E, Istre MS, Nygaard S, Utgard TR, Ceprnjic S, Reiakvam O, Edvardsen E, Westlye LT, Nygaard AB, Dahl JA, Nissen-Meyer LSH, Ihle-Hansen H, Holland P. Interstitial fluid rejuvenation through young-donor plasma exchange in cognitively impaired patients: a pilot safety and feasibility study. Geroscience. 2026 Jul 23. doi: 10.1007/s11357-026-02435-0. Online ahead of print.

    PubMed 42489967

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Plasma exchenge in people with Alzheimer Disease, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06234436, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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ADDITION-MCI Clinical Trial NCT06234436 | AzTrials