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Trial record 1 of 2 for:    telmisartan alzheimer
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Telmisartan vs. Perindopril in Hypertensive Mild-Moderate Alzheimer's Disease Patients (SARTAN-AD)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2015 by Dr. Sandra E Black, Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Alzheimer’s Drug Discovery Foundation
Information provided by (Responsible Party):
Dr. Sandra E Black, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02085265
First received: November 29, 2013
Last updated: December 21, 2015
Last verified: December 2015
  Purpose
The purpose of this project is to conduct a proof of concept study in patients with probable Alzheimer's Disease who have mild to moderate 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 Intervention Phase
Alzheimer's Disease Hypertension Drug: Perindopril Drug: Telmisartan Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Sandra E Black, Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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.


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

  • 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

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

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

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

Estimated Enrollment: 240
Study Start Date: March 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously established clinical diagnosis of probable AD dementia by the new McKhann criteria63
  2. Previous brain MRI or CT scan within the last 2 years to rule out exclusionary pathology, such as cortical stroke, tumour, subdural hematomas, malformations, etc.
  3. Age 55 years or older
  4. Established diagnosis of hypertension and on at least one hypertensive 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. Stable dose of a cholinesterase inhibitor (ChEI) and/or memantine for at least 3 months prior to the randomization visit
  11. HbA1C <8.5%. Patients with stable type II diabetes are eligible for the study if the following conditions are met: there have been no severe hypoglycemic events requiring third party intervention (e.g. emergency department visit) within 6 months, and medication therapy has been stable for at least 3 months and is limited to oral antidiabetic agents and/or basal insulin therapy no more than once per day
  12. Patients on medications for vascular risk factors (e.g., hypertension, cholesterol) must be on a stable dose for ≥3 months 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. Severe periventricular white matter disease (Fazekas score 3), cortical infarction, lacunar infarcts <1.5 cm diameter in basal ganglia or thalamus or >2 lacunar infarcts (<1.5cm diameter) elsewhere on screening MRI
  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
  14. Regular use of psychotropic medications, other than a short-acting benzodiazepine for sleep or non-anticholinergic antidepressants (stable dose for 3 months at time of randomization); exceptions (e.g. for antipsychotic medication) may be permitted on a case-by-case basis, upon consultation with Dr. Krista Lanctôt
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085265

Contacts
Contact: Sandra Black, MD 416.480.4551 sandra.black@sunnybrook.ca

Locations
Canada, Ontario
Parkwood Institute Not yet recruiting
London, Ontario, Canada, N6C 4R3
Principal Investigator: Michael Borrie, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Ljubica Zotovic, MD    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         
Sponsors and Collaborators
Dr. Sandra E Black
Alzheimer’s Drug Discovery Foundation
Investigators
Principal Investigator: Sandra Black, MD Sunnybrook Health Sciences Centre
Principal Investigator: Krista Lanctot, PhD Sunnybrook Research Institute
  More Information

Responsible Party: Dr. Sandra E Black, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02085265     History of Changes
Other Study ID Numbers: SARTAN-AD-001
Study First Received: November 29, 2013
Last Updated: December 21, 2015

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

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

ClinicalTrials.gov processed this record on September 21, 2017