A randomised, double blind, placebo controlled trial to evaluate the safety, efficacy and pharmakokinetics of Pleconaril as an add on to AchEI/memantine for treatment of patients with Alzheimer’s disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1) Male or female patients diagnosed with AD according to ICD-10
2) Age 60 to 85 years (inclusive) at the time of informed consent
3) Patient has stable AChEI and/or memantine for dementia (stable treatment is defined as stable in type of treatment and dose for at least 3 months prior to the baseline visit)
4) MMSE score 20 to 27 (inclusive) and judged by the Investigator to be able to give informed consent
5) Patients have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol, as judged by the Investigator
6) 12-lead ECG with normal tracings; or changes that are not clinically significant and do not require medical intervention, as judged by the Investigator
7) Patient has a relative or caregiver, judged as reliable by the Investigator, who has signed informed consent.
The relative or caregiver should participate in the patient’s visits at the clinic and assist the patient with drug compliance at home.
8) Willingness to participate after signing informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

1) Active hepatitis B, active hepatitis C, or HIV infection
2) Serious cardiac disease including unstable or uncontrolled cardiac disease during the last 6 months and/or previous history of deep vein thrombosis or clinical signs of deep venous thrombosis
3) Major psychiatric disorder (e.g. schizophrenia or past or present major depression disorder or as judged by the investigator)
4) Major surgical procedure within 4 weeks prior to inclusion
5) Women of childbearing potential (WOCBP) without reliable contraceptive method.
For the purpose of this trial, WOCBP includes any female who had experienced menarche, who had not undergone tubal ligation, and who is not postmenopausal. Post menopause was defined as amenorrhea = 12 consecutive months without another cause.
6) Previous stroke
7) Unstable treatment with Vitamin B12 medication, thyroid disorder medication, TNF-alpha blocking agents, antidepressants, cholinergic drugs, other AD medications (e.g. souvenaid)
Unstable treatment is defined as unstable in type of treatment and dose in the 3 months prior to the baseline visit. (Therefore, all patients not requiring such treatment or with stable treatment may be included)
8) Participation in any other clinical trial within 30 days of inclusion (randomisation) in the trial or patients with unresolved investigational treatment-related adverse events
9) Other chronic disease or previous organ transplantation judged by the Investigator to interfere with the assessment of treatment success and/or ability to fully participate in the trial
10) Patients that require immunosuppressive treatments including azathioprine, ciclosporin, systemic steroid treatment (e.g. prednisolone at doses of =10 mg/day or hydrocortisone) or has received such treatment within the last 6 months prior to randomization
11) Patients that are treated with drugs that can interact significantly with Pleconaril; ethinylestradiol
12) Lack of suitability for participation in the trial, for any reason, as judged by the Investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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