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

Astellas

Status and phase

Completed

Phase 4

Conditions

Cognition

Treatments

Drug: Oxybutynin

Drug: Placebo

Drug: Solifenacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01126424

905-EC-008

2008-005966-29 (EudraCT Number)

Details and patient eligibility

About

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

Full description

All subjects will receive each intervention during the course of the study. Subjects will complete a 21-day washout period between treatment periods and following last treatment period.

Enrollment

26 patients

Sex

All

Ages

75+ years old

Volunteers

Accepts Healthy Volunteers

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