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Not yet recruitingPhase 2

Improved Treatment and Monitoring of Alzheimer's Disease

Improved Treatment and Monitoring of Alzheimer's Disease - a Randomized Controlled Clinical Trial

Lead sponsor

Rune Skovgaard Rasmussen

Asset

Semaglutide

Listed sites

Recruiting sites

Enrollment

180

estimated

Study population

Alzheimer’s disease

Key I/E criterion

Primary endpoint

•Mini-Mental State Examination (MMSE)

Identifiers

Registered as

Org study ID523376

NCT IDNCT07135245

Timeline

Milestones

Study first posted2025-08-22actual

Last update posted2025-08-22actual

Study start2026-01-01estimated

Primary completion2030-09-30estimated

Study completion2031-09-30estimated

Assets

Drug assets

Semaglutide

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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.

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Memory

Behavior / neuropsychiatric

Amyloid biomarkers

Other (unclassified)

Neuroimaging

Fluid / digital biomarkers

Caregiver / quality of life

Global cognition

2 endpoints

Primary/protocol endpoint

The Montreal Cognitive Assessment

Time frame:At inclusion, and 52 and 78 weeks.

Mini-Mental State Examination (MMSE)

event count, event

Secondary/protocol endpoint

Clinical Dementia Rating scale - Sum of Boxes

Time frame:At inclusion, and 52 and 78 weeks.

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Memory

2 endpoints

Secondary/protocol endpoint

Quality of Life - Alzheimer's Disease (QoL-AD).

Time frame:At inclusion, and 52 and 78 weeks

descriptive

Secondary/protocol endpoint

The Rey-Osterrieth Complex Figure Test

Time frame:At inclusion, and 52 and 78 weeks.

descriptive

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

The Major Depression Inventory (MDI)

Time frame:At inclusion, and 52 and 78 weeks.

descriptive

Secondary/protocol endpoint

The 12-item Neuropsychiatric Inventory (NPI-12)

Time frame:At inclusion, and 52 and 78 weeks.

Neuropsychiatric Inventory (NPI)

descriptive

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Measurement of β-Amyloid1-42

Time frame:Performed at inclusion, and 6, 12, and 18 months.

descriptive

Secondary/protocol endpoint

PET scan of the brain

Time frame:At inclusion, and 52 and 78 weeks.

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

MRI scan of the brain

Time frame:At inclusion, and 52 and 78 weeks.

ratio, descriptive

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Measurement of Tau

Time frame:At inclusion, and 6, 12, and 18 months

Phosphorylated tau 217 (p-tau217)

descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

European Quality of Life-5 Dimensions Questionnaire (EuroQol-5D™, EQ-5D)

Time frame:At inclusion, and 52 and 78 weeks

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Symbol Digit Modalities Test

Time frame:At inclusion, and 52 and 78 weeks

event count, event

Secondary/protocol endpoint/low confidence

Patient Global Impression of Change (PGI-C).

Time frame:At inclusion, and 52 and 78 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.