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NCT03801642

Dapagliflozin In Alzheimer's Disease

Completed Phase 1, PHASE2 Results posted Last updated 13 June 2024
What this trial tests

Phase 1, PHASE2 trial testing Dapagliflozin in Alzheimer Disease in 46 participants. Completed in 7 July 2022.

Timeline
29 January 2019
Primary endpoint
7 July 2022
7 July 2022

Quick facts

Lead sponsorJeff Burns, MD
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment46
Start date29 January 2019
Primary completion7 July 2022
Estimated completion7 July 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jeff Burns, MD

Who can join

Adults 50 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ratio of Cerebral N Acetyl-Aspartate (NAA) / Cerebral Creatine Primary · 12 weeks

Estimated mean change from baseline in the ratio of cerebral NAA/ cerebral Creatine as measured by MRI Spectroscopy.

GroupValue95% CI
Dapagliflozin1.49± 0.11
Matching Placebo1.42± 0.09

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected from week 0 to week 12. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dapagliflozin
Serious: 0/30 (0%)
Deaths: 0/30
Matching Placebo
Serious: 0/16 (0%)
Deaths: 0/16
Other adverse events (20 terms — click to expand)

ReactionSystemDapagliflozinMatching Placebo
DizzinessEar and labyrinth disorders
Increase in Frequency of UrinationRenal and urinary disorders
ColdRespiratory, thoracic and mediastinal disorders
Discomfort with UrinationRenal and urinary disorders
Basal Cell Carcinoma RemovalSkin and subcutaneous tissue disorders
CoughRespiratory, thoracic and mediastinal disorders
COVID-19Respiratory, thoracic and mediastinal disorders
DiarrheaGastrointestinal disorders
FatigueEndocrine disorders
Poison IvySkin and subcutaneous tissue disorders
Hornet StingSkin and subcutaneous tissue disorders
Worsening in AnemiaBlood and lymphatic system disorders
Sinus InfectionRespiratory, thoracic and mediastinal disorders
FallInjury, poisoning and procedural complications
BronchitisRespiratory, thoracic and mediastinal disorders
Chest PainCardiac disorders
Upper Leg PainMusculoskeletal and connective tissue disorders
Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders
Upset StomachGastrointestinal disorders
Right Big Toe PainMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT03801642 adverse events section.

Sponsor's own description

This is a pilot randomized controlled trial in individuals with probable Alzheimer's disease testing the effects of 10 mg dapagliflozin, taken daily for 12 weeks, on cerebral n-acetyl aspartate (NAA) levels using magnetic resonance spectroscopy (MRS). The investigators will also examine the safety and tolerability of dapagliflozin and explore the effects on systemic NAA levels in blood and urine, cerebral metabolism (fluorodeoxyglucose \[FDG\] PET), systemic metabolic biomarkers that indicate and quantify secondary metabolic effects, and cognitive performance.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Alzheimer's disease drug development pipeline: 2019.
    Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
  2. Alzheimer's disease drug development pipeline: 2022.
    Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
  3. Alzheimer's disease drug development pipeline: 2020.
    Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
  4. Alzheimer's disease drug development pipeline: 2023.
    Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
  5. Alzheimer's disease drug development pipeline: 2021.
    Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179
  6. Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
    Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970
  7. Neuroprotective Effect of SGLT2 Inhibitors.
    Pawlos A, Broncel M, Woźniak E, Gorzelak-Pabiś P. · · 2021 · cited 207× · PMID 34885795 · DOI 10.3390/molecules26237213
  8. The brain as an insulin-sensitive metabolic organ.
    Milstein JL, Ferris HA. · · 2021 · cited 162× · PMID 33845179 · DOI 10.1016/j.molmet.2021.101234

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03801642.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing