A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mandelic Acids; Oxybutynin; Solifenacin Succinate

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