Telmisartan vs Perindopril for Alzheimer's Disease

(SARTAN-AD Trial)

No longer recruiting at 10 trial locations

Overseen By Ljubica Zotovic, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Cholinesterase inhibitors, Memantine

Must not be taking: Angiotensin receptor blockers

Disqualifiers: Type I diabetes, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether two medications, Telmisartan (also known as Micardis, an angiotensin receptor blocker) and Perindopril (an ACE inhibitor), can slow brain changes in people with mild to moderate Alzheimer's disease. The researchers aim to determine if these treatments can reduce brain shrinkage over a year. Suitable candidates for this trial have been diagnosed with Alzheimer's, have undergone a brain scan, and are experiencing symptoms without any stepwise decline. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in Alzheimer's treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you be on a stable dose of your current medications for at least 30 days before joining. This includes medications for Alzheimer's, vascular risk factors, and psychotropic medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that telmisartan, a drug commonly used for high blood pressure, has been tested for safety in over 3,700 people. More than 1,300 of these individuals used it for over a year without major issues. However, warnings exist. Long-term or high-dose use might harm the stomach or kidneys.

Perindopril, another blood pressure medication, has also been used safely by many patients. Both drugs have approval for treating high blood pressure, indicating general safety for this condition. However, their safety for individuals with Alzheimer's is still under study. Participants should discuss any concerns or side effects with their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Alzheimer's disease because they offer potential new ways to manage the condition. Telmisartan, traditionally used to treat high blood pressure, may protect brain cells by reducing inflammation and improving blood flow, which is a new approach compared to standard Alzheimer's treatments that typically target brain chemicals. Perindopril, another blood pressure medication, might also have unique neuroprotective effects that could help slow down Alzheimer's progression. Unlike existing therapies that primarily focus on memory symptoms, these treatments aim to tackle the underlying causes of cognitive decline, offering hope for improved brain health.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

This study will compare Perindopril and Telmisartan to determine if these treatments can slow brain changes in Alzheimer's by reducing brain shrinkage. Research has shown that Perindopril, an ACE inhibitor, helps manage high blood pressure and may protect brain health. It has been used successfully for heart conditions, lowering blood pressure and possibly supporting brain function. Telmisartan, an ARB, also effectively controls blood pressure. Studies have found that regular use of Telmisartan can stabilize blood pressure throughout the day. Although it hasn't significantly affected conditions like the growth of abdominal aortic aneurysms, it is being studied for potential brain health benefits due to its blood pressure-lowering effects. Both drugs focus on lowering blood pressure, which might indirectly benefit brain health. ^{6 7 8 9 10}

Who Is on the Research Team?

Sandra Black, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Krista Lanctot, PhD

Principal Investigator

Sunnybrook Research Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosis of Probable AD dementia or Possible AD dementia due to concomitant cerebrovascular disease (as permitted by the study exclusion criteria), using the 2011 McKhann criteria.

Previous brain MRI or CT scan to rule out exclusionary pathology, and absence of stepwise decline since the previous scan.

Your mental state will be assessed using a test, and if your score falls between 16 and 27, you may be excluded from the trial.

Exclusion Criteria

You have a type of Alzheimer's disease that runs in families and is inherited from one generation to another.

Creatinine clearance less than or equal to 30ml/min

Serum potassium > 5.5 mEq/L

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Telmisartan or Perindopril for 12 months to assess brain atrophy and other cognitive measures

12 months

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Perindopril
• Telmisartan

How Is the Trial Designed?

Group I: Telmisartan Experimental Treatment 1 Intervention

Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)

Group II: Perindopril Active Control 1 Intervention

Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Weston Brain Institute

Collaborator

Trials

13

Recruited

990+

Alzheimer's Drug Discovery Foundation

Collaborator

Trials

22

Recruited

3,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8126538/

Effectiveness of Telmisartan on Blood Pressure Control in ... Group-wise, patients on telmisartan + 1 AHD were most successful in achieving the SBP goal (39.7%), and patients on telmisartan + 2 AHDs were most successful in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02242370

Effectiveness of MICARDIS® (Telmisartan) on Blood ... Study Overview​​ Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's ...

3. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.107.094235

Comparison of the Efficacy of Morning Versus Evening ... Results of this study indicate that a single daily 80-mg/d dose of telmisartan in the morning reduces BP smoothly over the entire 24 hours. The same dose of ...

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2769749

Efficacy of Telmisartan to Slow Growth of Small Abdominal ... In this placebo-controlled randomized trial of 210 participants, a significant effect of telmisartan on abdominal aortic aneurysm growth rates was not shown.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2998248/

Clinical effectiveness of telmisartan alone or in combination ... The data showed that telmisartan did not significantly lower the rate of recurrent stroke (8.7% versus 9.2%; P = 0.23), major cardiovascular events (13.5% ...

6. sds.boehringer-ingelheim.com sds.boehringer-ingelheim.com/documents/00005518.PDF

SAFETY DATA SHEET MICARDIS,TABS/ 28/40MG MA/TN ... H373 May cause damage to organs (Stomach, Kidney) through prolonged or repeated exposure. Precautionary statements. : Prevention: P201 Obtain ...

7. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/11615m.pdf

Safety Data Sheet Chemical safety assessment: A Chemical Safety Assessment has not been carried out. 16 Other information. All chemicals may pose unknown hazards ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2011/020850s032lbl.pdf

Micardis (telmisartan) tablets - accessdata.fda.gov Hypertension. MICARDIS has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year.

9. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9ACDLB_TELMISARTAN_TAB_80MG_UD_30_BX.pdf

Safety Data Sheet Telmisartan Tablets, USP Strength Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure.

10. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/MSDS_9BEHGI_MICARDIS_HCT.pdf

MATERIAL SAFETY DATA SHEET CARCINOGENESIS/MUTAGENISIS: There was no evidence of carcinogenicity when Telmisartan was administered in the diet at 1000 mg/kg/day to mice ...