Phase 4
N=29
Trial of Carvedilol in Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01354444 ↗Enrolled (actual)
29
Serious AEs
10.3%
Results posted
Feb 2018
Primary outcome: Primary: Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months — 13; 12; 12; 13 Scores on a scale — p=0.565
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Carvedilol (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months |
13; 12; 12; 13; 12; 13 | 0.565 |
| SECONDARY Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers |
3.83; 0.129; 3.895; 0.117 | — |
| SECONDARY Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers |
3.83; 0.129; 3.895; 0.117 | — |
Summary
This is a 6-month pilot randomized double-blind placebo-controlled trial of carvedilol, with the primary objective being to determine whether carvedilol treatment is associated with improvement in Alzheimer's Disease (AD) as compared to placebo treatment. Secondary objectives are to monitor changes in cerebrospinal fluid amyloid levels and whether this dose will be safe and well-tolerated in AD patients. Clinical assessments will be performed at baseline, 3 months, and 6 months, while cerebrospinal fluid and blood samples will be obtained at baseline and 6 months.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of AD by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
- Mini-Mental State Exam (MMSE) 16-26. This range corresponds roughly to "mild" AD as rated by CDR below, and provides a rapid test for efficient screening of potential participants.
- Clinical Dementia Rating (CDR) = 3 months. These medications lack any notable effects on amyloid synthesis or metabolism and thus there is no reason to exclude them. The rationale behind requiring a stable dose is so that change in the trial can be attributed to the study intervention rather than recent changes of other medications affecting cognition.
- Patients will be allowed to remain on antidepressant and antipsychotics medications so long as the dose has been stable for >= 3 months. The rationale is the same as above.
- Knowledgeable informant available for all study visits. This is standard practice in AD research because many standard instruments and questionnaires in this trial require a knowledgeable informant.
Exclusion criteria
- Evidence of non-AD dementias including Huntington's disease, Parkinson's disease, or frontotemporal dementia.
2.Current Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV Axis I diagnoses other than dementia, including major depression, bipolar disorder, schizophrenia, anxiety disorders, alcohol abuse, or other substance abuse. These diagnoses would merit their own treatment plans and changes in these conditions could significantly affect cognitive and functional outcomes, confounding our efforts to study the efficacy of the study intervention.
- Any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed.
- Current use of Beta-blocking agents.
- Contraindications to use of Beta-blocking agents, to be determined in consultation with the patient's primary care physician or (if appropriate) cardiologist.
- Clinically significant hepatic or renal insufficiency.
Data sourced from ClinicalTrials.gov (NCT01354444). 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.