Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Perindopril; Drug: Telmisartan

• Registration Number: NCT02085265
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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).

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 Timeline

• Study First Submitted: 2013-11-29
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-12
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perindopril	Perindopril	Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)
Telmisartan	Telmisartan	Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)

Primary Outcome Measures

Name	Time	Method
Ventricular enlargement	12 months	Change in ventricular size, on 3D T1 MR imaging, after 12 months of treatment
Safety - Vital signs	12 months	Change in vital sign (heart rate, pulse) measurements after 12 months of treatment.
Safety - Electrolytes	12 months	Change in electrolyte measurements (Na, K) after 12 months of treatment.
Safety - Adverse Events	12 months	Adverse events and serious adverse events over 12 months of treatment.
Safety - Blood pressure	12 months	Change in blood pressure (BP) measurements after 12 months of treatment.

Secondary Outcome Measures

Name	Time	Method
Grey/White matter volume	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	6 and 12 months	Determine comparative efficacy of perindopril vs. telmisartan on cognitive and functional measures and on other structural brain imaging measures in this participant population
Hippocampal volume	12 months	Change in hippocampal volume measurements after 12 months of treatment

Trial Locations

Locations (10)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Lethbridge; 🇨🇦 Lethbridge, Alberta, Canada

UBC Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Parkwood Institute; 🇨🇦 London, Ontario, Canada

Centre for Memory and Aging; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Baycrest Health Sciences; 🇨🇦 Toronto, Ontario, Canada

Centre for Addiction and Mental Health (CAMH); 🇨🇦 Toronto, Ontario, Canada