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Safety and efficacy of plasma transfusion from exercise-trained donors in patients with early Alzheimer’s disease: the ExPlas Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518668-11-01
Acronym
ExPlas
Enrollment
60
Registered
2025-01-21
Start date
2021-09-17
Completion date
Unknown
Last updated
2025-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early symptomatic phase Alzheimer's disease

Brief summary

Proportion of patients with adverse events after 1 year as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.

Detailed description

Change in performance in the CERAD 10 word Test Change in the Mini-Mental State Examination (MMSE) score Change in performance in Trail-Making test A and B Change in scores in other cognitive tests: the Clock Drawing Test, Controlled Oral Word Association Test (COWAT)-FAS, Visual Object and Space Perception (VOSP) Silhouettes Change in Clinical Dementia Rating Scale Global score

Interventions

DRUGSALINE
DRUGOTHER PLASMA PROTEIN FRACTIONS
DRUGOctaplasma 45-70 mg/ml pulver og væske til infusjonsvæske
DRUGoppløsning

Sponsors

Norwegian University Of Science And Technolology
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients with adverse events after 1 year as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.

Secondary

MeasureTime frame
Change in performance in the CERAD 10 word Test Change in the Mini-Mental State Examination (MMSE) score Change in performance in Trail-Making test A and B Change in scores in other cognitive tests: the Clock Drawing Test, Controlled Oral Word Association Test (COWAT)-FAS, Visual Object and Space Perception (VOSP) Silhouettes Change in Clinical Dementia Rating Scale Global score

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026