Nasal Protollin in Early Symptomatic Alzheimer's Disease (NCT07187141) | Clinical Trial Compass
CompletedPhase 1
Nasal Protollin in Early Symptomatic Alzheimer's Disease
United States16 participantsStarted 2021-11-18
Plain-language summary
In this research study investigators aim to learn more about a new drug called Protollin as a possible new treatment for Alzheimer's Disease (AD). The primary goal is to assess the safety and tolerability.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The Sponsor will rely on NIA-AA Alzheimer's Disease Diagnostic Guidelines1 for Early Symptomatic Alzheimer's Disease and have a MMSE of 29-20.
. Age between 60-85 years (inclusive).
. Good general health with no disease expected to interfere with the study.
. On a stable medication regimen for 8 weeks prior to the study and which is anticipated to remain stable during the study.
. Subject is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile). ). If a woman is of childbearing potential, her partner is required to use contraception throughout the study (for those identifying as male).
. Amyloid-positive PET scan (if subject meets all other inclusion criteria).
. Ability to understand and provide informed consent.
Exclusion criteria
. Any significant neurologic disease including Parkinson's disease, multi-infarct dementia, Huntington's disease, frontotemporal dementia, Lewy body dementia, normal pressure hydrocephalus, brain tumor, brain hemorrhage with persistent neurologic deficits, progressive supra-nuclear palsy, seizure disorder, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on safety and tolerability of nasal Protollin — since it's not primarily designed to test whether the treatment actually works, what does that mean for understanding whether it could benefit someone with early Alzheimer's?
2The trial is listed as completed — has my doctor seen any of the published safety data yet, and does anything in those results stand out as a concern or a reason for optimism before larger studies move forward?
3Protollin is delivered nasally, which is an unusual route for an Alzheimer's treatment — can my doctor explain how this delivery method is supposed to work and why it was chosen for this kind of study?
4Since this was a dose-escalation safety trial, were there particular doses that raised concerns or appeared better tolerated, and would that affect whether I might be eligible for any follow-up trials?
5Given that this was an early-phase safety study and standard treatments already exist for early symptomatic Alzheimer's, would my doctor recommend exploring approved therapies first while watching for Phase 2 or 3 trials that build on this research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of ascending doses of nasal Protollin
Timeframe: Day 1 (enrollment) to 180 days (end of study)
. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease.
. History of autoimmune disease.
. Current treatment with immunomodulatory or immunosuppressive drugs, or corticosteroid administration by any route of administration (including nasal corticosteroids) within the past month.
. Major depression or bipolar disorder or a history of schizophrenia.
. History of alcohol or substance abuse or dependence within the past 2 years.
. History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment.
. Clinically significant abnormalities (defined as greater than mild on the FDA's vaccine toxicity scale) in screening laboratories.