Alzheimer's DiseasePhase 2SARTAN-ADNCT02085265
Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients
A Phase 2 study testing Perindopril and Telmisartan in people with Alzheimer's Disease, run by Sunnybrook Health Sciences Centre at 10 sites in Canada.
Trial 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)… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Perindopril and Telmisartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 10 sitesCanada
- Study dates
- Mar 2014to 28 Feb 2025
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
- 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.
Who cannot join
- Intolerance, or any contraindications, to study medications
- Average SBP <110mmHg or average DBP <60 mmHg during screening
- 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)
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- 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
- Any of the following findings on previous CT/MRI or on screening MRI:
- Exclusionary Finding: Malignant tumour Brain Location: Anywhere Size: Any 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: 1.0-1.5 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
University of Calgary
Calgary, Alberta, T2N 4N1
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
University of Lethbridge
Lethbridge, Alberta, T1K 6T5
Parkwood Institute
London, Ontario, N6C 4R3
Centre for Memory and Aging
Toronto, Ontario, M4G 3E8
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Baycrest Health Sciences
Toronto, Ontario, M6A 2E1
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario
UBC Hospital
Vancouver, British Columbia, V6T 2B5
About this study
Official title: The SARTAN-AD Trial: A Randomized, Open Label, Proof of Concept Study of Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients
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).
Read the detailed 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Perindopril, Telmisartan
- Keywords
- Alzheimer's Disease, Perindopril, Telmisartan, Brain atrophy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerindoprilDrug
Also called Coversyl
Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)
TelmisartanDrug
Also called Micardis
Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Telmisartan 40 mg or 80 mg/day (depending on age and tolerability) Receives: Drug: Telmisartan |
| Perindopril | Active comparator | Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability) Receives: Drug: Perindopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular enlargement
Change in ventricular size, on 3D T1 MR imaging, after 12 months of treatment
Measured: 12 months
Safety - Blood pressure
Change in blood pressure (BP) measurements after 12 months of treatment.
Measured: 12 months
Safety - Vital signs
Change in vital sign (heart rate, pulse) measurements after 12 months of treatment.
Measured: 12 months
Safety - Electrolytes
Change in electrolyte measurements (Na, K) after 12 months of treatment.
Measured: 12 months
Safety - Adverse Events
Adverse events and serious adverse events over 12 months of treatment.
Measured: 12 months
Secondary outcomes (3)
Hippocampal volume
Change in hippocampal volume measurements after 12 months of treatment
Measured: 12 months
Grey/White matter volume
Volume of grey and white matter in the cingulate, parietotemporal and dorsolateral frontal regions after 12 months of treatment
Measured: 12 months
Cognitive and functional measures
Determine comparative efficacy of perindopril vs. telmisartan on cognitive and functional measures and on other structural brain imaging measures in this participant population
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Why it stopped: Lack of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Weston Brain Institute
- Responsible party
- Principal investigator, Dr. Sandra E Black, Sunnybrook Health Sciences Centre
- Investigators
- Sandra Black, MD, Principal investigator, Sunnybrook Health Sciences CentreKrista Lanctot, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085265
- Sponsor's protocol ID
- 148-2013
- Acronym
- SARTAN-AD
- Status last verified
- May 2025
- First submitted
- 29 Nov 2013
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SARTAN-AD Trial: A Randomized, Open Label, Proof of Concept Study of Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT02085265
- Acronym / sponsor ID
- SARTAN-AD / 148-2013
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Perindopril, Telmisartan, Brain atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Alzheimer's Drug Discovery Foundation, Weston Brain Institute
- Study start
- Mar 2014
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: TelmisartanTelmisartan 40 mg or 80 mg/day (depending on age and tolerability) |
| Perindopril | Active comparator | Drug: PerindoprilPerindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (30 listed)
- Intolerance, or any contraindications, to study medications
- Average SBP <110mmHg or average DBP <60 mmHg during screening
- Familial autosomal dominant form of Alzheimer's disease
- Creatinine clearance less than or equal to 30ml/min
- Serum potassium > 5.5 mEq/L
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 |
|---|---|---|
| PerindoprilAlso: CoversylPerindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability) | Drug | Perindopril |
| TelmisartanAlso: MicardisTelmisartan 40 mg or 80 mg/day (depending on age and tolerability) | Drug | Telmisartan |
Primary outcome
Ventricular enlargement
Time frame: 12 months
Change in ventricular size, on 3D T1 MR imaging, after 12 months of treatment
Safety - Blood pressure
Time frame: 12 months
Change in blood pressure (BP) measurements after 12 months of treatment.
Safety - Vital signs
Time frame: 12 months
Change in vital sign (heart rate, pulse) measurements after 12 months of treatment.
Safety - Electrolytes
Time frame: 12 months
Change in electrolyte measurements (Na, K) after 12 months of treatment.
Safety - Adverse Events
Time frame: 12 months
Adverse events and serious adverse events over 12 months of treatment.
3 secondary outcomes
Hippocampal volume
Time frame: 12 months
Grey/White matter volume
Time frame: 12 months
Cognitive and functional measures
Time frame: 6 and 12 months
Results and safety
The study was stopped early (reason given: Lack of recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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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.
Sandra Black, MD principal investigator
Sunnybrook Health Sciences Centre
Krista Lanctot, PhD principal investigator
Sunnybrook Research Institute
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perindopril and Telmisartan in people with Alzheimer's Disease, run by Sunnybrook Health Sciences Centre at 10 sites in Canada.
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 9 inclusion and 30 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: stopped early, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular enlargement (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.