View Clinical Trial (Medical Research Study)
Pilot Trial of Carvedilol in Alzheimer's Disease
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21224 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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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.
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| Study Summary: |
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The purpose of the study is measure decline in episodic memory, in participants taking
carvedilol in early AD, when compared to placebo treatment. (as evidenced by the Hopkins
Verbal Learning Test [HVLT]). cerebrospinal fluid levels of Aβ oligomers in early AD, will
be measured in participants receiving carvedilol treatment when compared to placebo
treatment. Adverse effects will be monitored in participants receiving carvedilol when
compared to placebo.
To assess adverse events, routine chemistry and hematology studies, vital signs, and
electrocardiographic parameters before and after 6 months randomized placebo-controlled
double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing 25 early
AD participants taking carvedilol vs. 25 early AD participants taking placebo.
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| Criteria: |
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Inclusion Criteria:
1. Diagnosis of AD by NINCDS/ADRDA criteria (47)
2. 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.
3. Clinical Dementia Rating (CDR) < 1 (mild dementia). This corresponds with "early" AD
(see D.2.5 above). Participants will be eligible if they have AD diagnosis and CDR
of 0.5 or 1.0. The category of CDR 0.5 AD is particularly important to include as
these participants are in the earliest stage that can be diagnosed as dementia (as
opposed to mild cognitive impairment) and thus are in the "earliest" clinical stage
of AD.
4. Patients will be allowed to remain on current FDA-approved Alzheimer's treatments
including cholinesterase inhibitors and memantine, so long as the dose has been
stable for >= 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.
5. 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
item 5.
6. Knowledgeable informant available for all study visits. This is standard practice in
AD research because many standard instruments (in this trial including CDR, NPI,
ADCS-ADL) require a knowledgeable informant.
Exclusion criteria
1. Evidence of non-AD dementias including Huntington's disease, Parkinson's disease, or
frontotemporal dementia.
2. Current 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.
3. Any clinically significant medical condition that could interfere with the subject's
ability to safely participate in the study or to be followed.
4. Current use of Beta-blocking agents
5. Contraindications to use of Beta-blocking agents, to be determined in consultation
with the patient's primary care physician or (if appropriate) cardiologist.
6. Clinically significant hepatic or renal insufficiency.
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| NCT ID: |
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NCT01354444 |
| Primary Contact: |
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Principal Investigator
Paul B. Rosenberg, M.D.
Johns Hopkins University
Paul B Rosenberg, MD
Phone: 410-550-9883
Email: prosenb9@jhmi.edu
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| Backup Contact: |
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Email: jpedroso@jhmi.edu
Julia J. Pedroso, RN, MA
Phone: 410-550-9054
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| Location Contact: |
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Baltimore, Maryland 21224
United States
Julia J. Pedroso, RN, MA
Phone: 410-550-9054
Email: jpedroso@jhmi.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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