Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients (SARTAN-AD)

  • STATUS
    Recruiting
  • End date
    Sep 15, 2023
  • participants needed
    150
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 15 May 2022
diabetes
stroke
angiotensin
dementia
psychotropic drugs
mini-mental state examination
alzheimer's disease
mental state examination
memantine
cholinesterase inhibitors
cholinesterase
antihypertensive drugs
cholesterol level
perindopril
telmisartan

Summary

To conduct a proof of concept study in patients with mild to moderate Alzheimer's Disease in order to determine if there is less global brain atrophy over one year, as measured by ventricular enlargement as a primary outcome measure, when patients are randomized to treatment with an angiotensin receptor blocker (ARB) compared to an angiotensin converting enzyme inhibitor (ACEI).

Description

This study uses a simple validated measure of brain atrophy as a surrogate marker in a repurposing effort that could recast an antihypertensive medication as a cognitive enhancer/neuroprotective agent and possibly as a drug of choice for Alzheimer patients and patients at risk for AD. If the proof of concept result is positive, a larger study would be warranted with potential practice-changing impact.

Details
Condition Alzheimer's Disease
Treatment Telmisartan, Perindopril
Clinical Study IdentifierNCT02085265
SponsorSunnybrook Health Sciences Centre
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

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
Age 50 years or older
Standardized Mini Mental State Examination (SMMSE) score of 16-27 at screening visit
Sufficient hearing and vision to participate in testing as per investigator's judgement
Sufficient fluency in English to understand instructions and to be able to complete SMMSE
A study partner who in the opinion of the study investigator has regular interaction with the participant, can be present for study visits, can provide a collateral history and can ensure compliance with study procedures
Patients on cholinesterase inhibitors or memantine, medications for vascular risk factors (e.g., hypertension, cholesterol, diabetes), or on psychotropic medications must be on a stable dose for 30 days prior to randomization
HbA1C <8.5%. Patients with stable type II diabetes are eligible for the study if there have been no severe hypoglycemic events requiring third party intervention (e.g. emergency department visit) for 6 months prior to randomization

Exclusion Criteria

Average SBP <110mmHg or average DBP <60 mmHg during screening
Intolerance, or any contraindications, to study medications
Familial autosomal dominant form of Alzheimer's disease
Creatinine clearance less than or equal to 30ml/min
Serum potassium > 5.5 mEq/L
ALT 3x > the upper limit of normal (ULN)
History of angioedema
Co-morbid acute or chronic conditions (including type I diabetes mellitus, other neurological conditions such as Parkinson's disease, psychiatric disorders, and severe or unstable medical conditions) that could confound assessments or would, in the judgment of the investigator, make the subject inappropriate for entry into this study
Exclusionary Finding: Malignant tumour Brain Location: Anywhere Size: Any
Any of the following findings on previous CT/MRI or on screening MRI
Exclusionary Number: Any
Exclusionary Finding: Tumour with significant mass effect Brain Location
Anywhere Size: Sufficient for mass effect Exclusionary Number: Any
Exclusionary Finding: Vascular malformations Brain Location: Anywhere Size
Any Exclusionary Number: Any
Exclusionary Finding: Subdural hematoma Brain Location: Anywhere Size: Any
Exclusionary Number: Any
Exclusionary Finding: Intracerebral hemorrhage Brain Location: Anywhere Size
Any Exclusionary Number: Any
Exclusionary Finding: Cerebral microbleeds, Brain Location: Anywhere Size: Any
Exclusionary Number: more than 5
Exclusionary Finding: Superficial siderosis (SS) Brain Location: Cortex Size
Any Exclusionary Number: >1 instance of focal SS
Exclusionary Finding: Ischemic infarct Brain Location: Cortex Size: >1.5 cm in
diameter Exclusionary Number: Any
Exclusionary Finding: Ischemic infarct Brain Location: Cortex Size: ≤1.5 cm in
diameter Exclusionary Number: more than 1
Exclusionary Finding: Fazekas score 3 with white matter hyperintensity band
along the lateral surface of the ventricles >0.5 cm in width
Exclusionary Finding: Ischemic infarct Brain Location: White matter Size: >1.5
cm in diameter Exclusionary Number: Any
Exclusionary Finding: Ischemic infarct Brain Location: White matter Size
0-1.5 cm in diameter Exclusionary Number: More than 2
Exclusionary Finding: Ischemic infarct Brain Location: Basal ganglia Size
>1.0 cm in diameter Exclusionary Number: Any
Exclusionary Finding: Ischemic infarct Brain Location: Basal ganglia and white
matter Size: ≤1.0 cm in diameter Exclusionary Number: More than 4
Exclusionary Finding: Strategic infarct Brain Location: Thalamus Size: Any
Exclusionary Number: Any
Exclusionary Finding: Strategic infarct Brain Location: Hippocampus, Size: Any
Exclusionary Number: Any
Inability to perform the study procedures, including claustrophobia or contraindications for MRI
Currently on or has taken an angiotensin receptor blocker within 12 months of randomization visit
Resides in a nursing home (participants who reside in retirement homes may be included if they have a study partner who meets inclusion criterion #8)
Current major depression by clinical history or score greater than 18 on the Cornell Scale for Depression in Dementia
Documented potential cardiac source of brain infarction such as mechanical valve or atrial fibrillation that is untreated or treated with warfarin or an antiplatelet agent; atrial fibrillation treated with a novel oral anticoagulant is permitted, as is a history of remote, transient atrial fibrillation that has not recurred
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note