Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients

(SARTAN-AD Trial)

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

23 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Telmisartan?

Research shows that Telmisartan is effective in lowering blood pressure in patients with mild to moderate hypertension. It provides consistent 24-hour blood pressure control and has been shown to reduce cardiovascular risks in large-scale trials. ^{1 2 3 4 5}

Is telmisartan safe for human use?

Telmisartan, also known as Micardis, has been shown to be generally safe in humans, with common side effects including headache and dizziness. It has been well-tolerated in studies involving patients with hypertension, and no serious safety concerns have been reported. ^{1 2 6 7 8}

How does the drug Telmisartan differ from other treatments for hypertension?

Telmisartan is unique because it is a long-acting angiotensin II receptor blocker (ARB) that provides consistent 24-hour blood pressure control with once-daily dosing, and it has a longer elimination half-life compared to other ARBs, which helps maintain its effects throughout the day. ^{1 2 5 9 10}

What is the purpose of this trial?

This trial is testing blood pressure medications to see if they can slow brain shrinkage in patients with mild to moderate Alzheimer's Disease. The goal is to find out if these medications can protect the brain and slow down the progression of the disease.

Research Team

Sandra Black, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Krista Lanctot, PhD

Principal Investigator

Sunnybrook Research Institute

Eligibility Criteria

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

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

Treatment Details

Interventions

• Perindopril
• Telmisartan

Participant Groups

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+

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Pharmacological and clinical profile of telmisartan, a selective angiotensin II type-1 receptor blocker]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Use of ambulatory blood pressure monitoring to evaluate the selective angiotensin II receptor antagonist, telmisartan, and other antihypertensive drugs. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of telmisartan in modifying vascular risk. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Telmisartan/hydrochlorothiazide versus valsartan/hydrochlorothiazide in obese hypertensive patients with type 2 diabetes: the SMOOTH study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Telmisartan in the treatment of hypertension. [2022]

6. England pubmed.ncbi.nlm.nih.gov

An open-label study investigating the efficacy and safety of 12-96 weeks of telmisartan treatment in patients with hypertension. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Telmisartan reduces neointima volume and pulse wave velocity 8 months after zotarolimus-eluting stent implantation in hypertensive type 2 diabetic patients. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Effective treatment of hypertension by AT(1) receptor antagonism: the past and future of telmisartan. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Telmisartan: a review of its use in hypertension. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Telmisartan/Hydrochlorothiazide: a review of its use as fixed-dose combinations in essential hypertension. [2021]