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

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ClinicalTrials.gov Identifier: NCT02085265
Recruitment Status : Recruiting
First Posted : March 12, 2014
Last Update Posted : November 27, 2017
Alzheimer’s Drug Discovery Foundation
Weston Brain Institute
Information provided by (Responsible Party):
Dr. Sandra E Black, Sunnybrook Health Sciences Centre

Brief Summary:
To conduct a proof of concept study in patients with mild to moderate Alzheimer's Disease who have treated hypertension, 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 compared to an Angiotensin Converting Enzyme inhibitor (ACEI).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Hypertension Drug: Perindopril Drug: Telmisartan Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The SARTAN-AD Trial: A Randomized, Open Label, Proof of Concept Study of Telmisartan vs. Perindopril in Hypertensive Mild-Moderate Alzheimer's Disease Patients
Study Start Date : March 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Telmisartan
Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)
Drug: Telmisartan
Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)
Other Name: teva-telmisartan
Active Comparator: Perindopril
Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)
Drug: Perindopril
Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)
Other Name: Coversyl

Primary Outcome Measures :
  1. Ventricular enlargement [ Time Frame: 12 months ]
    Change in ventricular size, on 3D T1 MR imaging, after 12 months of treatment

  2. Safety - Blood pressure [ Time Frame: 12 months ]
    Change in blood pressure (BP) measurements after 12 months of treatment.

  3. Safety - Vital signs [ Time Frame: 12 months ]
    Change in vital sign (heart rate, pulse) measurements after 12 months of treatment.

  4. Safety - Electrolytes [ Time Frame: 12 months ]
    Change in electrolyte measurements (Na, K) after 12 months of treatment.

  5. Safety - Adverse Events [ Time Frame: 12 months ]
    Adverse events and serious adverse events over 12 months of treatment.

Secondary Outcome Measures :
  1. Hippocampal volume [ Time Frame: 12 months ]
    Change in hippocampal volume measurements after 12 months of treatment

  2. Grey/White matter volume [ Time Frame: 12 months ]
    Volume of grey and white matter in the cingulate, parietotemporal and dorsolateral frontal regions after 12 months of treatment

  3. Cognitive and functional measures [ Time Frame: 6 and 12 months ]

Other Outcome Measures:
  1. Neuropsychiatric Measures [ Time Frame: 6 & 12 months ]
  2. Quality of Life [ Time Frame: 6 & 12 months ]
    Change in caregiver burden and health-related quality of life after treatment

  3. Treatment responsiveness of Diffusion Tensor Imaging (DTI) [ Time Frame: 12 months ]
  4. Treatment responsiveness of resting state functional MRI (rsfMRI) [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. 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 criteria63
  2. Previous brain MRI or CT scan to rule out exclusionary pathology, such as cortical stroke, tumour, subdural hematomas, malformations, severe periventricular white matter disease, etc., and absence of stepwise decline since the previous scan.
  3. Age 50 years or older
  4. Established diagnosis of hypertension and on at least one antihypertensive medication
  5. Standardized Mini Mental State Examination (SMMSE) score of 16-27 at screening visit
  6. Sufficient hearing and vision to participate in testing as per investigator's judgement
  7. Sufficient fluency in English to be able to complete language and other cognitive tests
  8. At least 8 years of education
  9. A study partner who in the opinion of the study investigator has regular interaction with the patient, can be present for all clinic visits, can provide a collateral history and can assist in compliance with study procedures
  10. On a cholinesterase inhibitor (ChEI) and/or memantine (unless unable to tolerate); dose must be stable for 30 days prior to randomization
  11. 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
  12. Patients on 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.

Exclusion criteria

  1. Intolerance, or any contraindications, to study medications
  2. Familial autosomal dominant form of Alzheimer's disease
  3. Creatinine clearance less than or equal to 30ml/min
  4. Serum potassium > 5.5 mEq/L
  5. ALT > the upper limit of normal (ULN)
  6. History of angioedema
  7. Co-morbid acute or chronic conditions (including type I diabetes mellitus, stroke, other neurological conditions such as Parkinson's disease, and 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
  8. Any of the following findings on previous CT/MRI or on screening MRI:

    1. Severe periventricular white matter disease (Fazekas score 3);
    2. Cortical or subcortical infarct >1.5 cm in diameter;
    3. More than 1 cortical infarct;
    4. More than 2 subcortical lacunar infarcts (<1.5 cm diameter) in the basal ganglia or white matter;
    5. Strategic lacunar infarct in the thalamus;
    6. Intracerebral hemorrhage (any size);
    7. Any cortical superficial siderosis;
    8. More than 5 cerebral microbleeds.
  9. Inability to perform the study procedures, including claustrophobia or contraindications for MRI
  10. Currently on or has taken an angiotensin receptor blocker within 12 months of randomization visit
  11. Resides in a nursing home (participants who reside in retirement homes may be included if they have a study partner who meets inclusion criterion #9)
  12. Current major depression by clinical history or score greater than 18 on the Cornell Scale for Depression in Dementia
  13. Documented potential cardiac source of brain infarction such as mechanical valve or any type of atrial fibrillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085265

Contact: Sandra Black, MD 416.480.4551 sandra.black@sunnybrook.ca
Contact: Ljubica Zotovic, MD 416.480.6100 ext 3004 ljubica.zotovic@sunnybrook.ca

Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Ramnik Sekhon    403-210-7737    ramnik.sekhon@ucalgary.ca   
Contact: Anna Charlton    403-210-6164    acharlto@ucalgary.ca   
Principal Investigator: Eric Smith, MD         
University of Lethbridge Not yet recruiting
Lethbridge, Alberta, Canada, T1K 6T5
Contact: Keiko McCreary, PhD    403-394-3985    keiko.mccreary2@uleth.ca   
Principal Investigator: John Kennedy, MD         
Principal Investigator: Robert Sutherland, PhD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Mannie Fan    604-822-0550    mannie.fan@vch.ca   
Principal Investigator: Robin Hsiung, MD         
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Ben Connolly    289-440-1205    connollyb@HHSC.CA   
Principal Investigator: Demetrios (James) Sahlas, MD         
Parkwood Institute Not yet recruiting
London, Ontario, Canada, N6C 4R3
Principal Investigator: Michael Borrie, MD         
South East Toronto Family Health Team Not yet recruiting
Toronto, Ontario, Canada, M4C 5T2
Contact: Marcus Law, MD    416.699.7775    marcus.law@utoronto.ca   
Principal Investigator: Marcus Law, MD         
Centre for Memory and Aging Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact: Mayrose Cornejo    416-663-6897 ext 24    mcornejo@memorycentre.ca   
Contact: Josephine Accarrino    416-663-6897 ext 21    jaccarrino@memorycentre.ca   
Principal Investigator: Giovanni Marotta, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Ferhana Dhira    416-480-6103    ferhana.dhira@sunnybrook.ca   
Contact: Ljubica Zotovic    416-480-6100 ext 3004    ljubica.zotovic@sunnybrook.ca   
Principal Investigator: Sandra Black, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Corinne Fischer, MD         
Baycrest Health Sciences Not yet recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Brad Pugh    406.785.2500 ext 6207    b.pugh@baycrest.org   
Principal Investigator: Morris Freedman, MD         
Centre for Addiction and Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada
Contact: Apoorva Bhandari    416-535-8501 ext 33532    Apoorva.Bhandari@camh.ca   
Contact: Lina Chiuccariello    416-535-8501 ext 30409    Lina.Chiuccariello@camh.ca   
Principal Investigator: Sanjeev Kumar, MD         
University of Waterloo Not yet recruiting
Waterloo, Ontario, Canada, N2L 3G1
Contact: Laura Middleton, PhD    519-888-4567 ext 33045    lmiddlet@uwaterloo.ca   
Principal Investigator: Laura Middleton, PhD         
Principal Investigator: George Heckman, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Alzheimer’s Drug Discovery Foundation
Weston Brain Institute
Principal Investigator: Sandra Black, MD Sunnybrook Health Sciences Centre
Principal Investigator: Krista Lanctot, PhD Sunnybrook Research Institute

Responsible Party: Dr. Sandra E Black, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02085265     History of Changes
Other Study ID Numbers: 148-2013
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by Dr. Sandra E Black, Sunnybrook Health Sciences Centre:
Alzheimer's Disease
Brain atrophy

Additional relevant MeSH terms:
Alzheimer Disease
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors