Phase 2
N=77
Candesartan's Effects on Alzheimer's Disease And Related Biomarkers
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02646982 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants With a Hypotensive Episode — 16; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Candesartan (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Hypotensive Episode |
16; 4 | — |
| PRIMARY Number of Participants With Symptoms of Hypotension |
7; 10 | — |
| PRIMARY Number of Participants With Hypotensive Episodes and Symptoms |
4; 1 | — |
| PRIMARY Number of Participants With Elevated Serum Creatinine |
0; 0 | — |
| PRIMARY Number of Participants With Hyperkalemia |
0; 1 | — |
| PRIMARY Number of Participants Discontinuing Study Medication |
0; 1 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Total Tau Levels |
638.31; 529.04; 571.96; 441.25 | — |
| SECONDARY Cerebrospinal Fluid (CSF) of Tau Phosphorylated at Threonine 181 (p-tau181) Levels |
100.29; 81.58; 88.52; 68.49 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Amyloid Aβ42 Levels |
554.80; 523.03; 557.60; 476.32 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Amyloid Aβ40 Levels |
11624.00; 10802.00; 11769.00; 9735.00 | — |
| SECONDARY Cerebrospinal Fluid (CSF) Amyloid Aβ42/Aβ40 Levels |
0.049; 0.052; 0.050; 0.051 | — |
| SECONDARY Pulse Wave Velocity (PWV) |
7.81; 8.73; 7.71; 8.14 | — |
| SECONDARY Augmentation Index (AI) |
29.95; 31.22; 28.36; 26.66 | — |
| SECONDARY Hippocampal Volume |
6949.82; 6662.21; 6761.12; 6521.30 | — |
| SECONDARY Vasoreactivity |
0.27; -0.17 | — |
| SECONDARY Global Standardized Uptake Value Ratio (SUVR) of (11)C-Pittsburgh Compound B ((11)C-PiB) |
1.32; 1.42; 1.34; 1.46 | — |
| SECONDARY Global Standardized Uptake Value Ratio (SUVR) of [18F]T807 |
1.33; 1.36; 1.34; 1.34 | — |
| SECONDARY Clinical Dementia Rating (CDR) Score |
1.86; 1.85; 2.18; 2.21 | — |
| SECONDARY EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) Toolbox Composite Score |
0.03; -0.05; 0.18; 0.04; 0.07; -0.06 | — |
| SECONDARY Hopkins Verbal Learning Test (HVLT) Delayed Recall Score |
4.83; 5.29; 5.40; 5.08; 5.10; 5.39 | — |
| SECONDARY Trail Making Test (TMT) Part B |
149.44; 142.93; 122.04; 152.91; 148.06; 152.96 | — |
| SECONDARY Trail Making Test (TMT) Part B - A |
108.08; 91.56; 81.59; 102.38; 103.64; 103.50 | — |
Summary
This study is intended to investigate the safety of candesartan, a blood pressure medication, in non-hypertensive individuals who have mild cognitive impairment (MCI) due to Alzheimer's disease and its effect on disease biomarkers.
Eligibility Criteria
Inclusion Criteria
- Mild Cognitive Impairment, defined by:
- Subjective memory concern
- Abnormal memory function documented using the Logical Memory subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale-Revised (the maximum score is 25): [ 2.0 mg/dl), hyperkalemia (K>5.5 meq/dl), platelets 1.9
- Active medical or psychiatric diseases that in the judgment of the investigator would affect the safety of the subject or scientific integrity of the study
- Uncontrolled congestive heart failure reflected by poor exercise tolerance and shortness of breath
- History of stroke in the past 3 years
- Inability to have MRI (eg metal implants or cardiac pacemaker) with an exception for those who cannot have an MRI, if all other parts of the study are obtained successfully they may still be enrolled in the study, or cognitive assessment or inability to assess amyloid positivity (no lumbar puncture and no amyloid scan)
- History of increased intracranial pressure (ICP) or bleeding diathesis (from disease states or from use of anticoagulants such as warfarin, heparin and related products, rivaroxaban or Xarelto, apixaban or Eliquis, edoxaban or Savaysa, dabigatran or Pradaxa)
- Women of childbearing potential (non-menopausal)
- In those who are unable to demonstrate that they understood the details of the study (ie lack of decisional-capacity to consent), a study partner/surrogate who can sign on their behalf will be required, otherwise they will be excluded
- Current use of Lithium, as candesartan may increase lithium concentration to toxic levels
Data sourced from ClinicalTrials.gov (NCT02646982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.