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CompletedPhase 4Results posted

Trial of Carvedilol in Alzheimer's Disease

Pilot Trial of Carvedilol in Alzheimer's Disease

Lead sponsor

Johns Hopkins University

Asset

Carvedilol

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26•AD symptomatic therapy: stable

Primary endpoint

•Hopkins Verbal Learning Test (HVLT) Scores

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDNA_00035546

NCT IDNCT01354444

Timeline

Milestones

Study first posted2011-05-16estimated

Study start2011-06actual (month precision)

Primary completion2016-12actual (month precision)

Study completion2017-01actual (month precision)

Last update posted2018-02-06actual

Results first posted2018-02-06actual

Assets

Drug assets

Carvedilol

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Maximum age100 Years

SexAll

Healthy volunteersNot accepted

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) < 1 (mild dementia). This corresponds with "early" AD. 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.

•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.

•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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Memory

2 endpoints

Primary/protocol endpoint

Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months

Time frame:Baseline, 3 months, and 6 months

descriptive

Primary/registry result

Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months

Time frame:Baseline, 3 months, and 6 months

descriptive

Posted result

Group	Value (mean), Scores on a scale	Standard deviation
HVLT Score in Placebo GroupHVLT score at Baseline (immediate recall)n=15 Participants	13	4
HVLT score at 3 months (immediate recall)n=15 Participants	12	5
HVLT score at 6 months (immediate recall)n=15 Participants	12	5
HVLT score at Baseline (delayed recall)n=15 Participants	1	2
HVLT score at 3 months (delayed recall)n=15 Participants	1	2
HVLT score at 6 months (delayed recall)n=15 Participants	1	2
HVLT Score in Treatment GroupHVLT score at Baseline (immediate recall)n=14 Participants	12	6
HVLT score at 3 months (immediate recall)n=14 Participants	13	4
HVLT score at 6 months (immediate recall)n=14 Participants	13	6
HVLT score at Baseline (delayed recall)n=14 Participants	1	1
HVLT score at 3 months (delayed recall)n=14 Participants	1	2
HVLT score at 6 months (delayed recall)n=14 Participants	0	0

Coefficient1.4895% CI-3.796 - 6.761p0.565Regression, Linear

This analysis compares immediate recall before and after 6 months between the treatment and placebo group.

Amyloid biomarkers

4 endpoints

Secondary/protocol endpoint

Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers

Time frame:6 months

change from baseline, improvement

Secondary/registry result

Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers

Time frame:6 months

change from baseline, improvement

Posted result

Group	Value (mean), pg/mL	Standard deviation
CarvedilolBaseline Tau (pg/mL)n=6 Participants	169.476	93.931
Baseline ABeta42 (pg/mL)n=6 Participants	396.985	212.411
Baseline P tau (pg/mL)n=6 Participants	42.666	10.176
Six month Tau (pg/mL)n=6 Participants	222.461	139.839
Six month ABeta42 (pg/mL)n=6 Participants	499.325	174.308
Six month P tau (pg/mL)n=6 Participants	56.003	23.984
PlaceboBaseline Tau (pg/mL)n=10 Participants	169.484	48.386
Baseline ABeta42 (pg/mL)n=10 Participants	379.406	100.892
Baseline P tau (pg/mL)n=10 Participants	66.133	24.503
Six month Tau (pg/mL)n=10 Participants	171.757	53.72
Six month ABeta42 (pg/mL)n=10 Participants	361.563	89.044
Six month P tau (pg/mL)n=10 Participants	64.331	25.766

p0.481Rank sum test

This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.

p0.0562Rank sum test

This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.

p0.314Rank sum test

This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.

p0.438Rank sum test

This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.

Secondary/registry result

Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers

Time frame:6 months

change from baseline, improvement

Posted result

Group	Value (mean), ng/mL	Standard deviation
CarvedilolBaseline Oligomeric ABeta (ng/mL)n=6 Participants	3.83	3.314
Six month oligomeric ABeta (ng/mL)n=6 Participants	3.895	3.376
PlaceboBaseline Oligomeric ABeta (ng/mL)n=10 Participants	0.129	0.034
Six month oligomeric ABeta (ng/mL)n=10 Participants	0.117	0.101

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.