Status:
NOT_YET_RECRUITING
Improved Treatment and Monitoring of Alzheimer's Disease
Lead Sponsor:
Rune Skovgaard Rasmussen
Collaborating Sponsors:
Herlev Hospital
Conditions:
Alzheimer Disease (AD)
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
In the world's high-income countries, Alzheimer's disease and other dementia diseases are currently the second most common cause of death. This is a recent change, as strokes in the form of blood clot...
Eligibility Criteria
Inclusion
- Decreased cognitive abilities corresponding to 16-25 points in the Mini Mental State Examination (MMSE)
- The cognitive impairment must be supported by the presence of specific levels in cerebrospinal fluid (CSF) of β-Amyloid1-42 (≤1030 pg/ml) and Tau (total and phosphorylated, respectively over 300 pg/ml and 27 pg/ml)
- MRI scan of the brain with coronal sections showing substance loss (atrophy) of the medial part of the temporal lobe compatible with Alzheimer's disease
- PET scan of the brain (18F-FDG PET) with decreased regional glucose metabolism in the temporal and parietal regions and PiB (PiB-PET scan) with amyloid plaques in the brain compatible with Alzheimer's disease
Exclusion
- Patients with active cancer, and in chemo- or radiation therapy
- Severe cardiovascular disease.
- Hepatic insufficiency with ASAT\> 2 x upper limit of normal or renal insufficiency with serum creatinine \> 200 micromol/l
- Severe epilepsy with frequent tonic-clonic (grand mal) seizures
- Insulin treatment (type 1 diabetes mellitus) and diabetic ketoacidosis
- Severe chronic disease (e.g., cirrhosis, AIDS, chronic kidney failure)
- Severe mental illness e.g., schizophrenia, or physical disabilities leading to inability to participate in intervention or tests, or to provide informed consent
- Evidence for other primary causes of neurodegeneration or dementia, e.g., significant cerebrovascular disease (whose primary cause of dementia was vascular in origin), Lewy Body disease, Parkinson's disease, Fronto-temporal dementia
- Significant ongoing psychiatric or substance abuse problems.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2031
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07135245
Start Date
January 1 2026
End Date
September 30 2031
Last Update
August 22 2025
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