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 range60 Years – 85 Years

SexALL

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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.
✕. 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.

What they're measuring

Safety and tolerability of ascending doses of nasal Protollin

Timeframe: Day 1 (enrollment) to 180 days (end of study)

Trial details

NCT IDNCT07187141

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-22

View on ClinicalTrials.gov More Alzheimer Disease (AD) trials