Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT02500784|
Recruitment Status : Withdrawn (Funding ran out before study started, prior PI left institution.)
First Posted : July 17, 2015
Last Update Posted : September 16, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Cognitive Dysfunction||Drug: Formoterol A Other: Formoterol B (placebo)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Improving Beta-2 Adrenergic Signaling in Alzheimer's Disease|
|Estimated Study Start Date :||January 2023|
|Estimated Primary Completion Date :||April 2025|
|Estimated Study Completion Date :||July 2025|
Active Comparator: Formoterol A
12 months, formoterol, 20microgram/2ml, inhaler, BID
Drug: Formoterol A
20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.
Other Name: Performist
Placebo Comparator: Formoterol B
12 months, normal saline, 2ml, inhaler, BID
Other: Formoterol B (placebo)
2mL, BID inhaler for 12 months
- Cognition Evaluation [ Time Frame: 1 Month ]Participants will be administered the CANTAB every month for 16 months
- Brain-derived neurotrophic factor (BDNF) Evaluation [ Time Frame: Baseline and month 16 ]Samples of Plasma and Cerebral Spinal Fluid Biomarkers will be taken at baseline and month 16
- Amyloid accumulation [ Time Frame: Baseline and month 16 ]Molecular Imaging will be taken at baseline and month 16
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|Ages Eligible for Study:||50 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males and females between the ages of 50-85,
- Mild-to-moderate AD (NINCDS/ADRDA criteria for probable AD will be used to establish AD diagnosis).
- MMSE 16-26.
- Non-AD dementia or significant neurological disease such as Parkinson's disease, stroke, brain tumor,multiple sclerosis, seizure disorder, focal brain lesion, or head injury with loss of consciousness.
- Hypothyroidism, congestive heart failure (New York Heart Association Class III or IV), significant extrapyramidal symptoms on neurological examination, serum creatinine>1.3 mg/dl, significant arrhythmias or conduction defect abnormalities on ECG,
- Use of another beta2 adrenergic drug within the last 2 months.
- Residence in a long-term care facility.
- Evidence of any significant clinical disorder or laboratory finding that renders the person unsuitable for receiving an investigational new drug.
- Known hypersensitivity or prior exposure to formoterol.
- Active asthma or family history of asthma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500784
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Ahmad Salehi, M.D.,Ph.D.||Stanford Medical School|
|Responsible Party:||J. Wesson Ashford, Clinical Professor, VA Palo Alto Health Care System|
|Other Study ID Numbers:||
|First Posted:||July 17, 2015 Key Record Dates|
|Last Update Posted:||September 16, 2020|
|Last Verified:||September 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||No subjects enrolled|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action