Behavioural DisturbancesPhase 2NCT01608217
Delta-THC in Dementia
A Phase 2 study testing delta-9-tetrahydrocannabinol (delta-THC) and Acetaminophen in people with Behavioural Disturbances and Pain, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain in patients with mild to severe dementia, when added to an analgesic treatment with acetaminophen. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Behavioural Disturbances, Pain, Dementia
- What is being tested?
- delta-9-tetrahydrocannabinol (delta-THC) and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has possible or probable dementia, type Alzheimer, vascular or mixed type dementia, according to the criteria of NINCDS-ADRDA/NINCDS-AIREN or based on an expert panel decision.
- Clinical Dementia Rating (CDR) score 1 to 3 (mild to severe dementia).
- Age ≥ 40 years.
- Clinically relevant behavioral disturbances existing at least one month prior to screening, defined as a score of ≥ 10 on the NPI, including presence of the domain agitation/aggression or motor disturbance.
- Women should be in the postmenopausal phase.
- Availability of an informal or formal caregiver, being in touch with the subject at least twice a week.
- Informed consent by the subject and subject's informal caregiver.
- If applicable: subject is willing to stop his/her own pain medication, for the duration of the study.
Who cannot join
- Dementia other than AD, VaD or AD/VaD
- Major psychiatric disorder such as: major depression according to DSM IV within 6 months prior to randomization, history of psychosis or mania, current hallucinations and/or delirium, current suicidal ideation or major anxiety disorder.
- History of, or current drug abuse.
- Current alcohol abuse or unwillingness to use no more than 2 alcoholic consumptions daily or raised gamma-glutamine transpeptidase and alkaline phosphatase .
- Clinical or biochemical evidence of liver disease (ALT or AST ≥ twice the upper limit of normal) or known allergy to acetaminophen.
- Severe (and/or unstable) concomitant or intercurrent illness, such as seizure, arrhythmias requiring other drugs than a beta blocker or digoxin (except sinus arrhythmia and atrial fibrillation), unstable angina pectoris, heart failure NYHA III or IV, and severe concomitant illness that requires treatment changes.
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- Known or suspected sensitivity to cannabinoids.
- Lactosis intolerance.
- Frequent falling due to orthostatic hypotension.
- Use of tricyclic antidepressants (TCA), fluoxetine and/or carbamazepine.
- Changes in dosage of antipsychotics, benzodiazepines or cholinesterase inhibitors within 2 weeks prior to intervention.
- Participation in any other study other than the descriptive 'Parelsnoer' study.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboud university medical center, department of Geriatrics
Nijmegen, Gelderland, 6525
Vincent van Gogh Institute for Psychiatry, department of Elderly
Venlo, Limburg, 5912
About this study
Official title: Efficacy and Safety of Delta-9-tetrahydrocannabinol (∆9-THC) in Behavioural Disturbances and Pain in Dementia
This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain in patients with mild to severe dementia, when added to an analgesic treatment with acetaminophen.
It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period.
It is expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living.
Read the detailed description
There is a high prevalence of behavioural disturbances (NPS) in persons with dementia. Persistent pain complaints can be a cause of NPS. Unfortunately, there is a lack of appropriate drugs for treating both these problems. This and positive suggestions from preliminary clinical studies with THC on NPS and directly fuel the study presented here.
This will be a phase II study in which the efficacy and safety of Namisol® (a tablet with THC) on behavioural disturbances, such as agitation, aggression and motor disturbances in dementia patients will be evaluated.
Secondary study objectives are :
- To evaluate the efficacy of Namisol® on other secondary outcome measures, such as quality of life and functioning in daily activities.
- To evaluate safety of Namisol® as assessed with physical examination, effects on cognitive functioning and adverse event monitoring.
- For the subgroup of subjects suffering from pain: to evaluate the efficacy of Namisol® pain intensity
It is hypothesized that Namisol® will lead to more reduction in behavioural disturbances than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period. It is expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living
This is a randomized placebo-controlled double-blind parallel-group multicentre study.
Subjects who appear to fulfill the eligibility criteria are informed about the study. After signing informed consent by the subject and/or caregiver, a screening visit will take place. Subjects who are eligible for participation enter a wash-out period, for discontinuation of their own analgesic medication (if applicable). Subjects will be randomly allocated to receive one of the two interventions (Namisol® 1.5 mg + acetaminophen 1000 mg three times daily, or placebo + acetaminophen 1000 mg three times daily) for a double-blind intervention period of three weeks. After two weeks the primary outcome measure (NPI) is assessed by a telephone interview with the caregiver. Subjects visit the site twice (at baseline and after three weeks treatment) for assessments of the outcome parameters, including the NPI. For the purpose of compliance and safety, there will be a weekly phone call, performed by the researcher. After completion of this period subject's own analgesic treatment will be restarted (if applicable). After a follow up phase of two weeks, the subject is contacted by telephone for assessment of adverse events.
- Being tested
- delta-9-tetrahydrocannabinol (delta-THC), Placebo, Acetaminophen
- Keywords
- Behavioural disturbances, Pain, Dementia, Alzheimer's dementia, Vascular dementia, THC, Cannabis
- Medical subject headings
- Mental Disorders, Pain, Dementia, Alzheimer Disease, Dementia, Vascular, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delta-9-tetrahydrocannabinol (delta-THC)Drug
Also called Namisol, Cannabis, ECP002A
delta-THC 1.5 mg (tablet)three times daily for a period of 3 weeks.
PlaceboDrug
placebo (tablet) three times daily for a period of three weeks.
AcetaminophenDrug
Also called Paracetamol
Acetaminophen 1000 mg three times daily for a period of 3 weeks
AcetaminophenDrug
Also called Paracetamol
Acetaminophen 1000 mg three times daily for a period of three weeks
| Study group | Role | What they receive |
|---|---|---|
| Namisol | Active comparator | Namisol is a tablet containing delta-9-tetrahydrocannabinol, the main cannabinoid from Cannabis sativa L. Namisol is added to a standardized treatment with acetaminophen. Receives: Drug: delta-9-tetrahydrocannabinol (delta-THC); Drug: Acetaminophen |
| Placebo | Placebo comparator | The control product is placebo, consisting of a tablet with similar appearance and taste of the test product. Placebo is added to a standardized treatment with acetaminophen. Receives: Drug: Placebo; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Inventory (NPI)
The NPI has been accepted as the standard measure of NPS in most clinical trials, due to high validity, good inter-rater reliability, high internal consistency and its sensitivity to drug treatment effects. In clinical practice as well as clinical research the NPI is the most commonly used instrument to assess behavioral changes. The NPI evaluates 12 behavioral domains. The frequency and severity of these behaviors is scored by the informal caregiver.
Measured: Screening, baseline, T= 2 weeks (by telephone interview) and T=3 weeks
Secondary outcomes (8)
Pain Assessment Checklist for Seniors with Limited Ability to Communicate Dutch version (PACSLAC-D)
The PACSLAC-D is a brief version of Pain Assessment Checklist for Seniors with Limited Ability to Communicate in Dutch to observe pain related behavior It consists of 24 items, separated in three subscales (facial and vocal expressions, resistance/defense, social-economical aspects/mood). This scale is one of the few instruments in which the items are specifically geared towards elderly with dementia.
Measured: baseline (T = 0) and T= 3 weeks
Caregiver Clinical Global Impression of Change (CCGIC)
The CCGIC is a 7-point Likert scale that assesses global change from baseline. The scale ranges from 1 ('very much improved') to 7 ('very much worse'). It has been frequently used in several psychopharmacological trials and in early clinical trials for antidementia drugs. When the caregiver rates the subject as changed compared to baseline, this change is, by definition, clinically meaningful.
Measured: baseline (T=0), T= 2 wks (by telephone interview) and T=3 wks
Cohen-Mansfield Agitation Inventory (CMAI)
The CMAI is selected to assess agitation and aggression. It is an internationally validated instrument, specifically developed to measure behavioral disturbance in people with dementia
Measured: baseline (T=0) and T= 3 weeks
Quality of Life-Alzheimer's Disease Scale (QoL-AD)
The QoL-AD is a 13 -item self-report scale, using four-point Likert-scales, but can also be completed in conjunction with the interviewer. It is developed for assessment of quality of life in subjects with mild to moderate severe dementia, but there is also evidence for reliability in severe dementia.
Measured: baseline (T=0) and T= 3 weeks
Barthel Index
The Barthel Index was originally developed to assess disability in patients with neuromuscular and musculoskeletal conditions receiving rehabilitation, but is also recommended for functional assessment in elderly. Barthel Index is an easy to conduct, 10-item scale which scores several primary activities of daily living.
Measured: baseline (T=0) and T = 3 weeks
Paired Associates Learning test Wechsler Memory Scale Revised(PAL WMS-R)
The PAL is a WMS subtest for assessment of episodic memory function. The PAL is sensitive to midtemporal lobe dysfunction and therefore suitable for assessment of effects of THC on hippocampal functioning. This test entails the presentation of 10 pairs of common words that have to be remembered (6 semantically related and 4 unrelated pairs). After presentation of the word pairs, the researcher reads aloud the first word of each pair, which has to be completed by the subject, thereby assessing the capacity to recall.
Measured: baseline (T = 0) and T = 3 weeks
Safety assessments
Safety will be assessed by physical examination, including vital signs and internal examination. On indication extended physical (internal and neurological) examination or diagnostic tests can be performed. An ECG will be performed in all subjects during every visit. The occurrence of (serious) adverse events will be monitored, from first administration of study medication onwards. Weekly telephone calls are scheduled using a THC-specific symptom checklist to assess possible adverse events
Measured: screening, baseline (T=0), T= 3 weeks. AE and compliance during telephone calls at T= 1week, T= 2 weeks and T= 5 weeks (follow up phone call)
Verbal Rating Scale (VRS)
The VRS is an ordinal self-reporting scale for assessment of pain intensity. It is a 6-point scale consisting of a list of phrases that describe increasing levels of pain intensity. The subject selects that phrase best characterizing his/her pain intensity at that moment. In agreement with the Interdisciplinary Consensus Statement on Assessment of Pain in Older Persons the VRS is chosen as the self-reporting assessment method for pain intensity in this group with mild to moderate impaired cognitive function.
Measured: screening, baseline, T= 3 weeks, follow up (T= 5 weeks) and daily in a medication diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioural DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Valley, Netherlands
- Responsible party
- Principal investigator, Marcel Olde Rikkert, Radboud University Medical Center
- Investigators
- Marcel Olde Rikkert, prof. dr., Principal investigator, Radboud University Medical Center NijmegenWillem Verhoeven, Prof. dr., Principal investigator, Vincent van Gogh voor Geestelijke Gezondheidszorg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608217
- Sponsor's protocol ID
- GER001-02-02
- Other IDs
- 2011-005289-39, NL38617.091.12
- Status last verified
- Jun 2014
- First submitted
- 25 May 2012
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.
PubMed 34532852
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Delta-9-tetrahydrocannabinol (∆9-THC) in Behavioural Disturbances and Pain in Dementia
- ClinicalTrials.gov ID
- NCT01608217
- Acronym / sponsor ID
- GER001-02-02
- Keywords
- Behavioural disturbances, Pain, Dementia, Alzheimer's dementia, Vascular dementia, THC, Cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Health Valley, Netherlands
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain in patients with mild to severe dementia, when added to an analgesic treatment with acetaminophen.
It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period.
It is expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living.
Detailed description
There is a high prevalence of behavioural disturbances (NPS) in persons with dementia. Persistent pain complaints can be a cause of NPS. Unfortunately, there is a lack of appropriate drugs for treating both these problems. This and positive suggestions from preliminary clinical studies with THC on NPS and directly fuel the study presented here.
This will be a phase II study in which the efficacy and safety of Namisol® (a tablet with THC) on behavioural disturbances, such as agitation, aggression and motor disturbances in dementia patients will be evaluated.
Secondary study objectives are :
- To evaluate the efficacy of Namisol® on other secondary outcome measures, such as quality of life and functioning in daily activities.
- To evaluate safety of Namisol® as assessed with physical examination, effects on cognitive functioning and adverse event monitoring.
- For the subgroup of subjects suffering from pain: to evaluate the efficacy of Namisol® pain intensity
It is hypothesized that Namisol® will lead to more reduction in behavioural disturbances than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period. It is expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living
This is a randomized placebo-controlled double-blind parallel-group multicentre study.
Subjects who appear to fulfill the eligibility criteria are informed about the study. After signing informed consent by the subject and/or caregiver, a screening visit will take place. Subjects who are eligible for participation enter a wash-out period, for discontinuation of their own analgesic medication (if applicable). Subjects will be randomly allocated to receive one of the two interventions (Namisol® 1.5 mg + acetaminophen 1000 mg three times daily, or placebo + acetaminophen 1000 mg three times daily) for a double-blind intervention period of three weeks. After two weeks the primary outcome measure (NPI) is assessed by a telephone interview with the caregiver. Subjects visit the site twice (at baseline and after three weeks treatment) for assessments of the outcome parameters, including the NPI. For the purpose of compliance and safety, there will be a weekly phone call, performed by the researcher. After completion of this period subject's own analgesic treatment will be restarted (if applicable). After a follow up phase of two weeks, the subject is contacted by telephone for assessment of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Namisol | Active comparator | Drug: delta-9-tetrahydrocannabinol (delta-THC), Drug: AcetaminophenNamisol is a tablet containing delta-9-tetrahydrocannabinol, the main cannabinoid from Cannabis sativa L. Namisol is added to a standardized treatment with acetaminophen. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: AcetaminophenThe control product is placebo, consisting of a tablet with similar appearance and taste of the test product. Placebo is added to a standardized treatment with acetaminophen. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has possible or probable dementia, type Alzheimer, vascular or mixed type dementia, according to the criteria of NINCDS-ADRDA/NINCDS-AIREN or based on an expert panel decision.
- Clinical Dementia Rating (CDR) score 1 to 3 (mild to severe dementia).
- Age ≥ 40 years.
- Clinically relevant behavioral disturbances existing at least one month prior to screening, defined as a score of ≥ 10 on the NPI, including presence of the domain agitation/aggression or motor disturbance.
- Women should be in the postmenopausal phase.
Key exclusion criteria (12 listed)
- Dementia other than AD, VaD or AD/VaD
- Major psychiatric disorder such as: major depression according to DSM IV within 6 months prior to randomization, history of psychosis or mania, current hallucinations and/or delirium, current suicidal ideation or major anxiety disorder.
- History of, or current drug abuse.
- Current alcohol abuse or unwillingness to use no more than 2 alcoholic consumptions daily or raised gamma-glutamine transpeptidase and alkaline phosphatase .
- Clinical or biochemical evidence of liver disease (ALT or AST ≥ twice the upper limit of normal) or known allergy to acetaminophen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delta-9-tetrahydrocannabinol (delta-THC)Also: Namisol, Cannabis, ECP002Adelta-THC 1.5 mg (tablet)three times daily for a period of 3 weeks. | Drug | Namisol |
| Placeboplacebo (tablet) three times daily for a period of three weeks. | Drug | Placebo |
| AcetaminophenAlso: ParacetamolAcetaminophen 1000 mg three times daily for a period of 3 weeks | Drug | Namisol |
| AcetaminophenAlso: ParacetamolAcetaminophen 1000 mg three times daily for a period of three weeks | Drug | Placebo |
Primary outcome
Neuropsychiatric Inventory (NPI)
Time frame: Screening, baseline, T= 2 weeks (by telephone interview) and T=3 weeks
The NPI has been accepted as the standard measure of NPS in most clinical trials, due to high validity, good inter-rater reliability, high internal consistency and its sensitivity to drug treatment effects. In clinical practice as well as clinical research the NPI is the most commonly used instrument to assess behavioral changes. The NPI evaluates 12 behavioral domains. The frequency and severity of these behaviors is scored by the informal caregiver.
8 secondary outcomes
Pain Assessment Checklist for Seniors with Limited Ability to Communicate Dutch version (PACSLAC-D)
Time frame: baseline (T = 0) and T= 3 weeks
Caregiver Clinical Global Impression of Change (CCGIC)
Time frame: baseline (T=0), T= 2 wks (by telephone interview) and T=3 wks
Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: baseline (T=0) and T= 3 weeks
Quality of Life-Alzheimer's Disease Scale (QoL-AD)
Time frame: baseline (T=0) and T= 3 weeks
Barthel Index
Time frame: baseline (T=0) and T = 3 weeks
Paired Associates Learning test Wechsler Memory Scale Revised(PAL WMS-R)
Time frame: baseline (T = 0) and T = 3 weeks
Safety assessments
Time frame: screening, baseline (T=0), T= 3 weeks. AE and compliance during telephone calls at T= 1week, T= 2 weeks and T= 5 weeks (follow up phone call)
Verbal Rating Scale (VRS)
Time frame: screening, baseline, T= 3 weeks, follow up (T= 5 weeks) and daily in a medication diary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Derived from this study: PubMed 34532852Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.
- DementiaLink provided by the sponsor.
- TetrahydrocannabinolLink provided by the sponsor.
- CannabisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Olde Rikkert, prof. dr. principal investigator
Radboud University Medical Center Nijmegen
Willem Verhoeven, Prof. dr. principal investigator
Vincent van Gogh voor Geestelijke Gezondheidszorg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing delta-9-tetrahydrocannabinol (delta-THC) and Acetaminophen in people with Behavioural Disturbances and Pain, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory (NPI) (time frame: Screening, baseline, T= 2 weeks (by telephone interview) and T=3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.