A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability
Condition: Cognition
Intervention: Solifenacin; Oxybutynin; Placebo
Intervention description: tablet; capsule; tablet
Intervention MeSH terms: Solifenacin Succinate; Oxybutynin
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anti-muscarinics; Anti-cholinergics; Cognition; Solifenacin

Summary:

      The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any
      potential effects on mental ability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has mild cognitive impairment as determined by mini-mental state
             examination (MMSE) ≥ grade 24

          -  The subject conforms to the Stockholm criteria for mild cognitive impairment as
             assessed by the investigator

          -  The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive

          -  The subject is available to complete the study

        Exclusion Criteria:

          -  The subject has moderate or severe cognitive impairment as determined by MMSE criteria
             at screening, ≤ grade 23

          -  The subject has depression as determined by Geriatric Depression Scale (GDS) short
             form ≥ 5 at screening

          -  The subject has a history of urinary retention, severe gastrointestinal obstruction
             (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative
             colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior
             chamber or deemed to be at risk for these conditions

          -  The subject is undergoing hemodialysis or has severe renal impairment or moderate
             hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g.
             Ketoconazole

          -  The subject has uncontrolled diabetes mellitus

          -  The subject has a positive pre-study hepatitis B surface antigen, hepatitis C antibody
             or HIV result at time of screening

          -  The subject has a history of drug and / or alcohol abuse at time of screening

          -  The subject has an average weekly alcohol intake of greater than 21 units (male) or 14
             units (female) within ≤ 3 months prior to screening (1 unit is 270cc of beer, 40cc of
             spirits or 125cc of wine)

          -  The subject has a history of smoking more than 10 cigarettes (or the equivalent amount
             of tobacco) per day within ≤ 3 months prior to screening

          -  The subject has a history of known or suspected hypersensitivity to solifenacin
             succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose, to any
             component of the dosage form

          -  The subject has taken any unstable doses of prescribed medication within ≤ 1 month
             prior to screening or over-the-counter medicine (including vitamins and herbal
             remedies) within 48 hours prior to the first study day, which in the opinion of the
             Investigator, will interfere with the study procedures or compromise safety

          -  The subject is currently dosing with medication(s) intended to treat overactive
             bladder symptoms or has history of non-drug treatment intended to treat overactive
             bladder symptoms within ≤ 3 months prior to screening

          -  The subject has any clinically significant abnormality following Investigator review
             of the physical examination

          -  The subject has any clinically significant abnormality following the Investigator's
             review of the ECG

          -  The subject has mobility impairment that precludes the assessment of postural
             stability

          -  The subject has any clinically significant abnormal heart rate or blood pressure
             measurements, at the screening visit (dBP > 90mmHg, sBP > 160mmHg or HR < 40bpm or >
             100bpm)

          -  The subject has any clinically significant abnormality following Investigator's review
             of the biochemistry & hematology results which, in the opinion of the Investigator,
             contraindicates their participation

          -  The subject has donated blood or plasma within ≤ 3 months prior to screening or more
             than 500ml or 1 unit of blood or plasma within ≤ 6 months prior to screening

          -  The subject, may find it difficult to adhere to the provisions of treatment and
             observation specified in the protocol

          -  The subject has participated in any clinical study within ≤ 3 months prior to
             screening

          -  The subject has any clinical condition, diagnosis, symptomatology or ongoing
             investigation, which, contraindicates their participation

          -  The subject is an employee of Astellas Pharma, Cognitive Drug Research, and any other
             third party related to the study site