A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia

Phase 1

• Conditions: Clinically significant agitation in Alzheimer's Diseases; MedDRA version: 21.1Level: LLTClassification code 10001499Term: Agitation mentalSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: PTClassification code 10001497Term: AgitationSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]

• Registration Number: EUCTR2020-001056-17-GB
• Lead Sponsor: Kings's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age: 55-90.

Probable Alzheimer’s Disease diagnosis according to the criteria of National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDSADRDA).

Clinically significant A/A that requires treatment, defined by CMAI >/= 45 (Cohen-Mansfield et al., 1989) and/or NPI-NH Agitation total score >/= 4 (Livingston et al., 2017).

Residential within a nursing home at recruitment to the study with a history of at least 2 weeks behavioural disturbance.

Written and witnessed informed consent from participant (if deemed having mental capacity), or from personal legal representative (next of kin/power of attorney), or from professional legal representative (non R/F member who can attest to knowing prospective participant for significant period of time).
- Informed consent will be sought in this order from these potential sources.

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 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

-Anti-psychotic, anti-epileptic, antidepressant, benzodiazepine, lithium or hypnotic dosage alteration in the 2 weeks prior to the start of the study (and must be expected to maintain dosage throughout study).
-ChEIs (donepezil, rivastigmine or galantamine) and/or memantine, dosage alteration in the 6 weeks prior to the start of the study.
-Currently using cannabis-based medicine(s) (defined as being a UK licensed product prescribed by a doctor)
-Concomitant treatment with strong enzyme inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, St John’s Wort) and/or CYP3A4 inhibitors
-Hypersensitivity to Sativex® or any of the excipients in the formulation (ethanol anhydrous, Propylene glycol, peppermint oil).
-Severe cardiovascular disease, recent myocardial infarction (‘recency’ determined by study doctor according to clinical significance), uncompensated congestive heart failure and uncontrolled hypertension.
oQT interval by Fredericia (QTcF) greater than 450 will be excluded if ECG conducted
-Severe, unstable or poorly controlled medical illness.
-Renal Impairment as defined by estimated Glomerular Filtration Rate (eGFR) less than 45ml/min
-Hepatic impairment as defined by Alanine aminotransferase (ALT)/ Aspartate aminotransferase (AST) levels 3 times greater than reference value of laboratory (165 IU/L+ for ALT; 150 IU/L+ for AST)
-Any disability that may interfere with the patient completing the study procedure.
-History or family history of schizophrenia, or other psychotic illness; history of severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
-Delirium, pain or any medical illness as a clear cause of agitation
-Females of child-bearing potential, defined as ‘having experienced menarche and are not permanently sterilised (e.g. by hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period)’.
-Evidence of ‘suicidality risk’ determined by >0 on Columbia-Suicide Severity Rating Scale (C-SSRS)
-History/current seizure disorder
-History/current of alcohol or other substance abuse
-History of fall(s) within the last 6 months
7.2.1 COVID-19 specific exclusion criteria
-Positive COVID test result within previous 4 weeks
-Currently experiencing CV19 symptoms (continuous cough, high temperature, loss of taste/smell). NB. can be re-screened after 2 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified