A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia
Condition: Alzheimer's Disease or Vascular Dementia
MeSH terms: Alzheimer Disease; Dementia; Dementia, Vascular
Intervention: BAC treatment; Matched vehicle
Intervention description: BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks; BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Vehicle-Controlled, Parallel, Phase II Study to Evaluate Efficacy
      and Safety of BAC in Patient with Alzheimer's Disease or Vascular Dementia
    

Eligibility criteria:

        Inclusion Criteria:

          1. With either gender aged at least 40 years old

          2. With a diagnosis of one of the following disease i. Vascular dementia according to the
             NINDS-AIREN International Workshop criteria or ii. Alzheimer's disease according to
             the NIAAA criteria iii. "Mixed" dementia (possible Alzheimer's disease with
             cerebrovascular disease) according to the NIAAA criteria

             Note:

               1. NINDS-AIREN: National Institute of Neurological Disorders and Stroke and
                  Association Internationale pour la Recherche et l'Enseignement en Neurosciences

               2. NIAAA: National Institute on Aging-Alzheimer's Association

          3. With mild-to-moderate dementia (score of the Mini-Mental State Examination (MMSE)
             defined as between 10 to 24 and score of ADAS-Cog as at least 12)

          4. Able to read, write, communicate, and understand cognitive testing instructions

          5. Having a responsible caregiver who spends at least 4 hours daily with the patient. The
             caregiver will accompany the patient to all study visits, , supervise administration
             of study drug, and be able to assess the patient's condition

          6. Patients and the responsible caregiver willing and able to provide written informed
             consent form

        Exclusion Criteria:

          1. With large vessel thrombosis (thrombotic stroke occurring in large arteries)

          2. With radiological evidence of other brain disorders (subdural hematoma, post-traumatic
             / post-surgery)

          3. With dementia caused by other brain diseases except Alzheimer's disease and vascular
             dementia (e.g. Parkinson's disease, demyelinated disease of the central nervous
             system, tumor, hydrocephalus, head injury, central nervous system infection including
             syphilis, acquired immune deficiency syndrome, etc.)

          4. With clinical evidence of pulmonary, hepatic, gastrointestinal, metabolic, endocrine
             or other life threatening diseases judged by investigators not suitable to enter the
             study

          5. With clinically unstable hypertension, diabetes mellitus, and cardiac disease for the
             last 3 months

          6. Ever hospitalized for stroke or with acute coronary syndrome in the previous 3 months
             prior to screening

          7. Drug or alcohol abuse within the previous 12 months of screening.

          8. With one of the following abnormal laboratory parameters: hemoglobin < 10 mg/dL or
             platelet < 100*109/L; creatinine or total bilirubin more than 1.5 times the upper
             limit value; alanine aminotransferase (ALT), aspartate aminotransferase (AST),
             alkaline phosphates (ALP), γ-glutamyl transferase (γ-GT) more than 2 times the upper
             limit of normal, or thyroid-stimulating hormone (TSH) more than 2.5 times the upper
             limit value or less than the lower limit value of normal

          9. With severe depression graded by Diagnostic and Statistical Manual of Mental
             Disorders, Fifth Edition (DSM-5) and Cornell Scale for Depression in Dementia (CSDD)

         10. With any uncontrolled illness (including, but not limited to, any of the following:
             ongoing or active infection including hepatitis B, C, and HIV, active bleeding,
             symptomatic congestive heart failure, uncontrolled hypertension, unstable angina
             pectoris or, cardiac arrhythmia) judged by the investigator that entering the trial
             may be detrimental to the patient

         11. With known or suspected hypersensitivity to any ingredients of study product and
             vehicle

         12. Pregnant or lactating or premenopausal with childbearing potential but not taking
             reliable contraceptive method(s) during the study period

             Note: Reliable contraceptive methods will consider as below:

               1. Established use of oral, injected or implanted hormonal methods of contraception
                  > 3 months prior to baseline.

               2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) > 3 months
                  prior to baseline.

               3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
                  cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

               4. Partner male sterilization (i.e., vasectomy) > 1 month of screening

         13. Enrollment in any investigational drug trial within 4 weeks of screening visit

         14. Experienced dosage increment of routinely use in drugs listed as follows within past
             three months before Screening visit

               1. medications/treatments for Alzheimer's disease or vascular dementia

               2. antipsychotic medications including but not limited to selective serotonin
                  reuptake inhibitors (SSRIs), benzodiazepine (BZD)

               3. Vitamin B12

               4. drugs for thyroid disease

         15. Current antiplatelet drug (antiaggregant) except dosage including but not limited to
             aspirin <= 100mg/day, clopidogrel <= 75mg/day, ticagrelor <= 180mg/day, dipyridamole
             <= 400mg/day

         16. Caregivers who have psychotic symptoms, are imminently suicidal, have an unstable
             medical condition (e.g. recent heart attack, recent stroke, episodes of dizziness,
             fainting attacks) or significant orthopaedic problems.