Stroke, IschemicPhase 2/3DECISTNCT05565976
Dapagliflozin Effect in Cognitive Impairment in Stroke Trial
A Phase 2/3 study testing Dapagliflozin 10mg Tab, Statins (Cardiovascular Agents) and Platelet Antiaggregant in people with Stroke, Ischemic and Mild Cognitive Impairment, run by Jaime Daniel Mondragon at 1 site in Mexico.
Trial summary
Background: Dementia is an international public health problem, affecting approximately 50,000,000 people worldwide in 2018 and will triple by 2050; furthermore, reaching an approximate cost of 4 billion dollars. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Stroke, Ischemic, Mild Cognitive Impairment, Dementia, Vascular
- What is being tested?
- Dapagliflozin 10mg Tab, Statins (Cardiovascular Agents) and Platelet Antiaggregant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2020to 1 Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 60 and 80 years
- Both sexes
- Cerebrovascular ischemic event within 15 days
- Clinical dementia rating score ≤ 0.5
- Signed informed consent
Who cannot join
- Type 1 diabetes mellitus
- Aphasia
- Incomplete neuropsychological battery
- Previously diagnosed dementia
- Cerebrovascular ischemic stroke older than 15 days
- History of hemorrhagic cerebrovascular event
Show all 19Show fewer
- Neoplasia diagnosis or evidence of a metastatic process, glomerular filtration rate < 45 mL/min at the time of inclusion
- Liver enzyme test alterations (i.e., aspartate transaminase or alanine transaminase three times greater than normal levels, total bilirubin> 2.0 mg/dL
- Previously taking SGLT2 inhibitors
- History of diabetic ketoacidosis
- Recurrent urinary tract infections
- Psychiatric disorders (e.g., dementia, psychosis, bipolar disorder, among others).
- Less than a 12-month follow-up
- Inability to perform chest CT (e.g., claustrophobia)
- Incomplete medical files pertaining to the variables of interest
- Less than 12-month follow-up
- Decision to withdraw their participation at any moment
- Poor adherence to medical treatment
- Reported and documented disease complications or adverse effects (e.g., severe glycemic imbalance, diabetic ketoacidosis, or hyperosmolar hyperglycemic state, altered hepatic enzyme tests)
Trial locations and contacts
1 site in 1 country.
Lourdes N Vélez-Ramírez, M.D. contact
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de Zona IMSS 21
León, Guanajuato, 37380
Omar Jiménez-Zarazúa, M.D., +524423421626, drzarazuainterna@hotmail.com
Gabriela G López-Hernández, M.D.
About this study
Background: Dementia is an international public health problem, affecting approximately 50,000,000 people worldwide in 2018 and will triple by 2050; furthermore, reaching an approximate cost of 4 billion dollars. Given its high worldwide prevalence and probable underdiagnosis, the international guidelines for the assessment of dementia syndromes recommend the assessment of cognitive impairment in patients over 55 years of age as part of clinical practice in patients who presented an ischemic cerebrovascular event. Several risk factors associated with cognitive impairment in cerebrovascular disease are identified in the literature: 1) demographic factors (e.g., age over 65 years and female sex); 2) risk factors present prior to the ischemic stroke (e.g., cognitive impairment, physical impairment); 3) factors utilized to assess the severity of an ischemic stroke (e.g., supratentorial location, ischemic stroke in the dominant hemisphere, recurrence of ischemic strokes); 4) post-ischemic stroke factors (e.g., delirium and seizures); and 5) factors associated with neuroimaging findings (e.g., cerebral small vessel disease, cortical atrophy, and medial temporal lobe atrophy).
This is a randomized controlled trial in individuals with an acute ischemic stroke without dementia that will be treated with 10mg dapagliflozin PO q24h for 12 months and standard treatment against only standard treatment (i.e., statins, platelet antiaggregant, and hypoglycemic medications) when appropriate. The outcome measure evaluated will be global cognitive function. Cardiovascular risk factors will be associated with cognitive decline.
Read the detailed description
Detailed Description: This is a double-blind, randomized, placebo-controlled, parallel-group, 12-month longitudinal study performed at a single center (Hospital General de Zona con Medicina Familiar IMSS No. 21, León Guanajuato, México) designed to investigate the effect of dapagliflozin in participants with a recent acute stroke but no history of dementia (CDR score ≤ 0.5). A total of 270 participants are to be included (i.e., 135 on each arm).
Overall objective: To assess the effect of Dapagliflozin on cardiovascular risk (i.e., the volume of epicardial fat, volume of total carotid atherosclerotic plaque, and coronary artery calcium score) in patients with ischemic cerebrovascular disease dependent on global cognitive function at a second level teaching hospital in Mexico.
Statistical analysis: Descriptive statistics will be reported for all included variables. Statistical analysis will be performed using SPSS 25 (SPSS Inc., Chicago, IL). All variables will be examined to determine the existence of outliers and whether they meet the assumptions about a Gaussian distribution. The Shapiro-Wilk tests will be used to determine normality distribution, as well as visual inspection of histograms and Q-Q plots. Demographic and clinical variables will be summarized in proportions and percentages. The categorical variables will be evaluated to determine statistical inferences with the Mann-Whitney U test. Continuous variables will be assessed for statistical inferences using t-tests (e.g., simple, paired, one, and two samples) and Levene's test to assess equality of variances. The Kaplan-Meier method will be used to calculate the distributions of mortality and development of mild amnestic cognitive disorder and dementia syndrome. The Gehan-Breslow-Wilcoxon method will be used to assess the equality of the mortality distributions and the development of mild amnestic cognitive disorder or dementia syndrome. A multivariate analysis will be performed with a Cox regression model to assess the variables that predict mortality, and the development of a mild amnestic cognitive disorder, or dementia syndrome at 6 and 12 months in case there are differences in mortality distributions. Statistical significance will be set at p=0.05 and a Bonferroni correction will be performed for multiple comparisons.
- Being tested
- Dapagliflozin 10mg Tab, Statins (Cardiovascular Agents), Platelet Antiaggregant, Antidiabetic
- Keywords
- dapagliflozin, mortality, cognitive impairment
- Medical subject headings
- Ischemic Stroke, Cognitive Dysfunction, Dementia, Vascular, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called FORXIGA
10mg PO q24h for 12 months
Statins (Cardiovascular Agents)Drug
Also called Atorvastatin, Pravastatin, Rosuvastatin
Atorvastatin 20mg PO q24h or Pravastatin 20mg PO q24h or Rosuvastatin 10mg PO q24h
Platelet AntiaggregantDrug
Also called Clopidogrel, Acetylsalicylic acid
Clopidogrel 75mg PO q24h or Acetylsalicylic acid 100mg PO q24h
AntidiabeticDrug
Also called Sulfonylureas, Meglitinides, Biguanides, Thiazolidinediones
Previously established medical treatment for type 2 diabetes will be maintained.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | 10mg PO q24h for 12 months plus standard treatment with statins, platelet antiaggregant, and hypoglycemic medications. Receives: Drug: Dapagliflozin 10mg Tab; Drug: Statins (Cardiovascular Agents); Drug: Platelet Antiaggregant; Drug: Antidiabetic |
| Standard treatment | Active comparator | Standard treatment with statins, platelet antiaggregant, and hypoglycemic medications. Receives: Drug: Statins (Cardiovascular Agents); Drug: Platelet Antiaggregant; Drug: Antidiabetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Dementia Rating score as a proxy of cognitive deterioration
Time-to-event analysis using the Kaplan-meier survival analysis via increase in Clinical Dementia Rating score greter or equal to 0.5
Measured: 6 and 12 months
Secondary outcomes (1)
Number of strokes after initial cerebrovascular event
Independent stroke events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Aug 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaime Daniel Mondragon
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General León, Hospital General de Zona IMSS N0. 21, University Medical Center Groningen
- Responsible party
- Sponsor-investigator, Jaime Daniel Mondragon, Universidad de Guanajuato
- Investigators
- Gabriela G López-Hernández, M.D., Study chair, Hospital General de Zona IMSS 21Lizeth C Ramírez-Zamudio, M.D., Study chair, Hospital General de Zona IMSS 21Jaime D Mondragón, M.D., Ph.D., Principal investigator, University Medical Center Groningen, Department of Neurology, Alzheimer Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565976
- Sponsor's protocol ID
- F-2022-1005-016
- Acronym
- DECIST
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan and informed consent form are available through the IMSS platform or upon request.
Publications
Bjergfelt SS, Sorensen IMH, Hjortkjaer HO, Landler N, Ballegaard ELF, Biering-Sorensen T, Kofoed KF, Lange T, Feldt-Rasmussen B, Sillesen H, Christoffersen C, Bro S. Carotid plaque thickness is increased in chronic kidney disease and associated with carotid and coronary calcification. PLoS One. 2021 Nov 23;16(11):e0260417. doi: 10.1371/journal.pone.0260417. eCollection 2021.
PubMed 34813630Cherney DZI, Dekkers CCJ, Barbour SJ, Cattran D, Abdul Gafor AH, Greasley PJ, Laverman GD, Lim SK, Di Tanna GL, Reich HN, Vervloet MG, Wong MG, Gansevoort RT, Heerspink HJL; DIAMOND investigators. Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial. Lancet Diabetes Endocrinol. 2020 Jul;8(7):582-593. doi: 10.1016/S2213-8587(20)30162-5.
PubMed 32559474Dekkers CCJ, Petrykiv S, Laverman GD, Cherney DZ, Gansevoort RT, Heerspink HJL. Effects of the SGLT-2 inhibitor dapagliflozin on glomerular and tubular injury markers. Diabetes Obes Metab. 2018 Aug;20(8):1988-1993. doi: 10.1111/dom.13301. Epub 2018 Apr 23.
PubMed 29573529Dhillon S. Dapagliflozin: A Review in Type 2 Diabetes. Drugs. 2019 Jul;79(10):1135-1146. doi: 10.1007/s40265-019-01148-3.
PubMed 31236801Diaz-Rodriguez E, Agra RM, Fernandez AL, Adrio B, Garcia-Caballero T, Gonzalez-Juanatey JR, Eiras S. Effects of dapagliflozin on human epicardial adipose tissue: modulation of insulin resistance, inflammatory chemokine production, and differentiation ability. Cardiovasc Res. 2018 Feb 1;114(2):336-346. doi: 10.1093/cvr/cvx186.
PubMed 29016744Esterline R, Oscarsson J, Burns J. A role for sodium glucose cotransporter 2 inhibitors (SGLT2is) in the treatment of Alzheimer's disease? Int Rev Neurobiol. 2020;155:113-140. doi: 10.1016/bs.irn.2020.03.018. Epub 2020 Aug 11.
PubMed 32854852Esterline RL, Vaag A, Oscarsson J, Vora J. MECHANISMS IN ENDOCRINOLOGY: SGLT2 inhibitors: clinical benefits by restoration of normal diurnal metabolism? Eur J Endocrinol. 2018 Apr;178(4):R113-R125. doi: 10.1530/EJE-17-0832. Epub 2018 Jan 25.
PubMed 29371333Fani L, van Dam-Nolen DHK, Vernooij M, Kavousi M, van der Lugt A, Bos D. Circulatory markers of immunity and carotid atherosclerotic plaque. Atherosclerosis. 2021 May;325:69-74. doi: 10.1016/j.atherosclerosis.2021.03.040. Epub 2021 Apr 7.
PubMed 33894597Iacobellis G, Gra-Menendez S. Effects of Dapagliflozin on Epicardial Fat Thickness in Patients with Type 2 Diabetes and Obesity. Obesity (Silver Spring). 2020 Jun;28(6):1068-1074. doi: 10.1002/oby.22798. Epub 2020 Apr 30.
PubMed 32352644Iadecola C, Duering M, Hachinski V, Joutel A, Pendlebury ST, Schneider JA, Dichgans M. Vascular Cognitive Impairment and Dementia: JACC Scientific Expert Panel. J Am Coll Cardiol. 2019 Jul 2;73(25):3326-3344. doi: 10.1016/j.jacc.2019.04.034.
PubMed 31248555Ihara M, Saito S. Drug Repositioning for Alzheimer's Disease: Finding Hidden Clues in Old Drugs. J Alzheimers Dis. 2020;74(4):1013-1028. doi: 10.3233/JAD-200049.
PubMed 32144994Jabbour S, Seufert J, Scheen A, Bailey CJ, Karup C, Langkilde AM. Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials. Diabetes Obes Metab. 2018 Mar;20(3):620-628. doi: 10.1111/dom.13124. Epub 2017 Oct 26.
PubMed 28950419Jellinger KA, Attems J. Prevalence of dementia disorders in the oldest-old: an autopsy study. Acta Neuropathol. 2010 Apr;119(4):421-33. doi: 10.1007/s00401-010-0654-5. Epub 2010 Mar 4.
PubMed 20204386McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
PubMed 31535829Mijajlovic MD, Pavlovic A, Brainin M, Heiss WD, Quinn TJ, Ihle-Hansen HB, Hermann DM, Assayag EB, Richard E, Thiel A, Kliper E, Shin YI, Kim YH, Choi S, Jung S, Lee YB, Sinanovic O, Levine DA, Schlesinger I, Mead G, Milosevic V, Leys D, Hagberg G, Ursin MH, Teuschl Y, Prokopenko S, Mozheyko E, Bezdenezhnykh A, Matz K, Aleksic V, Muresanu D, Korczyn AD, Bornstein NM. Post-stroke dementia - a comprehensive review. BMC Med. 2017 Jan 18;15(1):11. doi: 10.1186/s12916-017-0779-7.
PubMed 28095900
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin Effect in Cognitive Impairment in Stroke Trial
- ClinicalTrials.gov ID
- NCT05565976
- Acronym / sponsor ID
- DECIST / F-2022-1005-016
- Keywords
- dapagliflozin, mortality, cognitive impairment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Jaime Daniel MondragonUniversity, hospital or other
- Collaborators
- Hospital General León, Hospital General de Zona IMSS N0. 21, University Medical Center Groningen
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Dementia is an international public health problem, affecting approximately 50,000,000 people worldwide in 2018 and will triple by 2050; furthermore, reaching an approximate cost of 4 billion dollars. Given its high worldwide prevalence and probable underdiagnosis, the international guidelines for the assessment of dementia syndromes recommend the assessment of cognitive impairment in patients over 55 years of age as part of clinical practice in patients who presented an ischemic cerebrovascular event. Several risk factors associated with cognitive impairment in cerebrovascular disease are identified in the literature: 1) demographic factors (e.g., age over 65 years and female sex); 2) risk factors present prior to the ischemic stroke (e.g., cognitive impairment, physical impairment); 3) factors utilized to assess the severity of an ischemic stroke (e.g., supratentorial location, ischemic stroke in the dominant hemisphere, recurrence of ischemic strokes); 4) post-ischemic stroke factors (e.g., delirium and seizures); and 5) factors associated with neuroimaging findings (e.g., cerebral small vessel disease, cortical atrophy, and medial temporal lobe atrophy).
This is a randomized controlled trial in individuals with an acute ischemic stroke without dementia that will be treated with 10mg dapagliflozin PO q24h for 12 months and standard treatment against only standard treatment (i.e., statins, platelet antiaggregant, and hypoglycemic medications) when appropriate. The outcome measure evaluated will be global cognitive function. Cardiovascular risk factors will be associated with cognitive decline.
Detailed description
Detailed Description: This is a double-blind, randomized, placebo-controlled, parallel-group, 12-month longitudinal study performed at a single center (Hospital General de Zona con Medicina Familiar IMSS No. 21, León Guanajuato, México) designed to investigate the effect of dapagliflozin in participants with a recent acute stroke but no history of dementia (CDR score ≤ 0.5). A total of 270 participants are to be included (i.e., 135 on each arm).
Overall objective: To assess the effect of Dapagliflozin on cardiovascular risk (i.e., the volume of epicardial fat, volume of total carotid atherosclerotic plaque, and coronary artery calcium score) in patients with ischemic cerebrovascular disease dependent on global cognitive function at a second level teaching hospital in Mexico.
Statistical analysis: Descriptive statistics will be reported for all included variables. Statistical analysis will be performed using SPSS 25 (SPSS Inc., Chicago, IL). All variables will be examined to determine the existence of outliers and whether they meet the assumptions about a Gaussian distribution. The Shapiro-Wilk tests will be used to determine normality distribution, as well as visual inspection of histograms and Q-Q plots. Demographic and clinical variables will be summarized in proportions and percentages. The categorical variables will be evaluated to determine statistical inferences with the Mann-Whitney U test. Continuous variables will be assessed for statistical inferences using t-tests (e.g., simple, paired, one, and two samples) and Levene's test to assess equality of variances. The Kaplan-Meier method will be used to calculate the distributions of mortality and development of mild amnestic cognitive disorder and dementia syndrome. The Gehan-Breslow-Wilcoxon method will be used to assess the equality of the mortality distributions and the development of mild amnestic cognitive disorder or dementia syndrome. A multivariate analysis will be performed with a Cox regression model to assess the variables that predict mortality, and the development of a mild amnestic cognitive disorder, or dementia syndrome at 6 and 12 months in case there are differences in mortality distributions. Statistical significance will be set at p=0.05 and a Bonferroni correction will be performed for multiple comparisons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg Tab, Drug: Statins (Cardiovascular Agents), Drug: Platelet Antiaggregant, Drug: Antidiabetic10mg PO q24h for 12 months plus standard treatment with statins, platelet antiaggregant, and hypoglycemic medications. |
| Standard treatment | Active comparator | Drug: Statins (Cardiovascular Agents), Drug: Platelet Antiaggregant, Drug: AntidiabeticStandard treatment with statins, platelet antiaggregant, and hypoglycemic medications. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages of 60 and 80 years
- Both sexes
- Cerebrovascular ischemic event within 15 days
- Clinical dementia rating score ≤ 0.5
- Signed informed consent
Key exclusion criteria (19 listed)
- Type 1 diabetes mellitus
- Aphasia
- Incomplete neuropsychological battery
- Previously diagnosed dementia
- Cerebrovascular ischemic stroke older than 15 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabAlso: FORXIGA10mg PO q24h for 12 months | Drug | Dapagliflozin |
| Statins (Cardiovascular Agents)Also: Atorvastatin, Pravastatin, RosuvastatinAtorvastatin 20mg PO q24h or Pravastatin 20mg PO q24h or Rosuvastatin 10mg PO q24h | Drug | Dapagliflozin, Standard treatment |
| Platelet AntiaggregantAlso: Clopidogrel, Acetylsalicylic acidClopidogrel 75mg PO q24h or Acetylsalicylic acid 100mg PO q24h | Drug | Dapagliflozin, Standard treatment |
| AntidiabeticAlso: Sulfonylureas, Meglitinides, Biguanides, ThiazolidinedionesPreviously established medical treatment for type 2 diabetes will be maintained. | Drug | Dapagliflozin, Standard treatment |
Primary outcome
Change in Clinical Dementia Rating score as a proxy of cognitive deterioration
Time frame: 6 and 12 months
Time-to-event analysis using the Kaplan-meier survival analysis via increase in Clinical Dementia Rating score greter or equal to 0.5
1 secondary outcome
Number of strokes after initial cerebrovascular event
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Results publication: PubMed 34813630Bjergfelt SS, Sorensen IMH, Hjortkjaer HO, Landler N, Ballegaard ELF, Biering-Sorensen T, Kofoed KF, Lange T, Feldt-Rasmussen B, Sillesen H, Christoffersen C, Bro S. Carotid plaque thickness is increased in chronic kidney disease and associated with carotid and coronary calcification. PLoS One. 2021 Nov 23;16(11):e0260417. doi: 10.1371/journal.pone.0260417. eCollection 2021.
- Results publication: PubMed 32559474Cherney DZI, Dekkers CCJ, Barbour SJ, Cattran D, Abdul Gafor AH, Greasley PJ, Laverman GD, Lim SK, Di Tanna GL, Reich HN, Vervloet MG, Wong MG, Gansevoort RT, Heerspink HJL; DIAMOND investigators. Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial. Lancet Diabetes Endocrinol. 2020 Jul;8(7):582-593. doi: 10.1016/S2213-8587(20)30162-5.
- Results publication: PubMed 29573529Dekkers CCJ, Petrykiv S, Laverman GD, Cherney DZ, Gansevoort RT, Heerspink HJL. Effects of the SGLT-2 inhibitor dapagliflozin on glomerular and tubular injury markers. Diabetes Obes Metab. 2018 Aug;20(8):1988-1993. doi: 10.1111/dom.13301. Epub 2018 Apr 23.
- Results publication: PubMed 31236801Dhillon S. Dapagliflozin: A Review in Type 2 Diabetes. Drugs. 2019 Jul;79(10):1135-1146. doi: 10.1007/s40265-019-01148-3.
- Results publication: PubMed 29016744Diaz-Rodriguez E, Agra RM, Fernandez AL, Adrio B, Garcia-Caballero T, Gonzalez-Juanatey JR, Eiras S. Effects of dapagliflozin on human epicardial adipose tissue: modulation of insulin resistance, inflammatory chemokine production, and differentiation ability. Cardiovasc Res. 2018 Feb 1;114(2):336-346. doi: 10.1093/cvr/cvx186.
- Results publication: PubMed 32854852Esterline R, Oscarsson J, Burns J. A role for sodium glucose cotransporter 2 inhibitors (SGLT2is) in the treatment of Alzheimer's disease? Int Rev Neurobiol. 2020;155:113-140. doi: 10.1016/bs.irn.2020.03.018. Epub 2020 Aug 11.
- Results publication: PubMed 29371333Esterline RL, Vaag A, Oscarsson J, Vora J. MECHANISMS IN ENDOCRINOLOGY: SGLT2 inhibitors: clinical benefits by restoration of normal diurnal metabolism? Eur J Endocrinol. 2018 Apr;178(4):R113-R125. doi: 10.1530/EJE-17-0832. Epub 2018 Jan 25.
- Results publication: PubMed 33894597Fani L, van Dam-Nolen DHK, Vernooij M, Kavousi M, van der Lugt A, Bos D. Circulatory markers of immunity and carotid atherosclerotic plaque. Atherosclerosis. 2021 May;325:69-74. doi: 10.1016/j.atherosclerosis.2021.03.040. Epub 2021 Apr 7.
- Results publication: PubMed 32352644Iacobellis G, Gra-Menendez S. Effects of Dapagliflozin on Epicardial Fat Thickness in Patients with Type 2 Diabetes and Obesity. Obesity (Silver Spring). 2020 Jun;28(6):1068-1074. doi: 10.1002/oby.22798. Epub 2020 Apr 30.
- Results publication: PubMed 31248555Iadecola C, Duering M, Hachinski V, Joutel A, Pendlebury ST, Schneider JA, Dichgans M. Vascular Cognitive Impairment and Dementia: JACC Scientific Expert Panel. J Am Coll Cardiol. 2019 Jul 2;73(25):3326-3344. doi: 10.1016/j.jacc.2019.04.034.
- Results publication: PubMed 32144994Ihara M, Saito S. Drug Repositioning for Alzheimer's Disease: Finding Hidden Clues in Old Drugs. J Alzheimers Dis. 2020;74(4):1013-1028. doi: 10.3233/JAD-200049.
- Results publication: PubMed 28950419Jabbour S, Seufert J, Scheen A, Bailey CJ, Karup C, Langkilde AM. Dapagliflozin in patients with type 2 diabetes mellitus: A pooled analysis of safety data from phase IIb/III clinical trials. Diabetes Obes Metab. 2018 Mar;20(3):620-628. doi: 10.1111/dom.13124. Epub 2017 Oct 26.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan and informed consent form are available through the IMSS platform or upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes N Vélez-Ramírez, M.D. contact
Gabriela G López-Hernández, M.D. study chair
Hospital General de Zona IMSS 21
Lizeth C Ramírez-Zamudio, M.D. study chair
Hospital General de Zona IMSS 21
Jaime D Mondragón, M.D., Ph.D. principal investigator
University Medical Center Groningen, Department of Neurology, Alzheimer Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin 10mg Tab, Statins (Cardiovascular Agents) and Platelet Antiaggregant in people with Stroke, Ischemic and Mild Cognitive Impairment, run by Jaime Daniel Mondragon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Jiménez-Zarazúa, M.D. (+524423421626, drzarazuainterna@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Dementia Rating score as a proxy of cognitive deterioration (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05565976, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.