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

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

180

Study population

Alzheimer's / cognition

Eligibility highlights

Primary endpoint

•Montreal Cognitive Assessment

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07135245

Org study ID523376

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

Investigational agents

Semaglutide

Who this study enrolls

Alzheimer's / cognition

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

Other clinical outcomes

Patient-reported / QoL

Other (unclassified)

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

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

Time frame:At inclusion, and 52 and 78 weeks

descriptive, improvement

Secondary/protocol endpoint

Patient Global Impression of Change (PGI-C).

Time frame:At inclusion, and 52 and 78 weeks

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:At inclusion, and 52 and 78 weeks

EQ-5D index

descriptive, improvement

Secondary/protocol endpoint

The Major Depression Inventory (MDI)

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

change from baseline, improvement

Secondary/protocol endpoint

The 12-item Neuropsychiatric Inventory (NPI-12)

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

change from baseline, improvement

Other clinical outcomes

7 endpoints

Primary/protocol endpoint

The Montreal Cognitive Assessment

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

descriptive, improvement

Secondary/protocol endpoint/low confidence

Measurement of Tau

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

descriptive

Secondary/protocol endpoint/low confidence

MRI scan of the brain

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

descriptive

Secondary/protocol endpoint/low confidence

PET scan of the brain

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

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating scale - Sum of Boxes

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

change from baseline, improvement

Secondary/protocol endpoint

Symbol Digit Modalities Test

Time frame:At inclusion, and 52 and 78 weeks

descriptive, improvement

Secondary/protocol endpoint/low confidence

The Rey-Osterrieth Complex Figure Test

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

descriptive, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Measurement of β-Amyloid1-42

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

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

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 6, 2026 snapshot.