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

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Updated on 15 May 2022

See if I qualify

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 Identifier	NCT02085265
Sponsor	Sunnybrook Health Sciences Centre
Last Modified on	15 May 2022

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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

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Study Definition

Wikipedia

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