Trial · NCT02615002

Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)

NCT02615002, Phase 2, Completed, Neurim Pharmaceuticals Ltd.; results first posted 2024-07-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION). Trials, record NCT02615002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02615002

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Piromelatine in Mild Alzheimer's Disease Patients (ReCOGNITION)
NCT number: NCT02615002
Status: Completed
Phases: Phase 2
Enrollment: 371 participants, actual
Lead sponsor: Neurim Pharmaceuticals Ltd.
Conditions: Alzheimer's Disease
Interventions: Piromelatine, Placebo
First posted: 2015-11-25
Last updated: 2024-07-05
Results first posted: 2024-07-05

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline	26 weeks	The global composite score of the cNTB combines the International Shopping List Test (ISLT), One Card Learning (OCL), Identification (IDN), Detection (DET), One Back Card (OBK), Controlled Oral Word Association Test (COWAT), and the Categorical Fluency Test (CFT). For each test, a z-score relative to the study baseline is calculated. The cNTB global composite score is the mean of all z-scores from the tests listed above. The scale range is from -3 to 3. Zero Z-score means no cognitive change. A negative value means decline, while a positive value means improvement.
Secondary	Change From Baseline in Global Impression of Change (CGIC)	13 weeks, and 26 weeks	The Change From Baseline in Global Impression of Change (CGIC) rating is made on a 7-point Likert-type scale where the change from baseline is rated as marked improvement (1), moderate improvement (2), minimal improvement (3), no change (4), minimal worsening (5), moderate worsening (6), marked worsening (7). Mean values at 13 and 26 weeks are relative to baseline.
Secondary	Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for MCI (Mild Cognitive Impairment) Patients (ADCS-MCI-ADL)	Baseline, 13 weeks, and 26 weeks	ADCS-MCI-ADL is an evaluation scale with information provided by an informant/caregiver to describe the functional impairment of patients with mild cognitive impairment (MCI). The ADCS-ADL is a 23-item scale that includes 6 basic ADLs (BADLs) and 17 Instrumental Activities of Daily Living (IADLs) that provide a total score of 0-78, with a lower score indicating greater severity, meaning a worse outcome.
Secondary	Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog14)	Baseline, 13 weeks, and 26 weeks	The ADAS was designed to measure the severity of the most important symptoms of AD. Its subscale, ADAS-cog, is the most popular cognitive testing instrument used in clinical trials, measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD. ADAS-cog14 comprises 14 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment.
Secondary	Safety and Tolerability - Blood Pressure (mmHg)	Baseline, and 26 weeks	Systolic and Diastolic Blood Pressure is followed during the study, as safety and tolerability measures. Changes in BP following treatment, leading to values out of the normal limits mean a worse outcome.
Secondary	Safety and Tolerability - Heart Rate (Bpm)	Baseline, and 26 weeks	Heart Rate within normal limits = 60-100 beats per minute (bpm) during the study means a good outcome in terms of safety.
Secondary	Safety and Tolerability - ECG Interval Results - QTcF (Msec)	Baseline, and 26 weeks	QT interval corrected for heart rate by Fridericia's cube root formula (QTcF). The QTc is considered normal at \< 450 msec in males, and \< 470 msec in females.
Secondary	Safety and Tolerability - Hematology	Baseline, and 26 weeks	Hematology (GI/L). 1 gill (GI) = 0.118294118 liter (L). No major changes or shifts from baseline mean good safety and tolerability.
Secondary	Safety and Tolerability - Blood Chemistry (mmol/L)	Baseline, and 26 weeks	Blood Chemistry follow-up during the experiment. No major changes or shifts from baseline mean good safety and tolerability.
Other	NeuroPsychiatric Inventory (NPI) Total Score	Baseline, and 26 weeks	The NPI scale consists of 12 domains that are rated for both frequency (range 1 to 4) and severity (range 1 to 3). A composite score for each domain is calculated (frequency × severity), and it ranges from 1 to 12. For each item, there is a leading question. If the symptom is absent, then the frequency, severity, and distress scores are not completed. In this case, the score is 0 for the item. The sum of the composite scores yields the NPI total score (1-12). A negative change in the score indicates an improvement from baseline (symptom reduction).

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline	26 weeks	z-score	MEAN
SECONDARY	Change From Baseline in Global Impression of Change (CGIC)	13 weeks, and 26 weeks	score on a scale	MEAN
SECONDARY	Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for MCI (Mild Cognitive Impairment) Patients (ADCS-MCI-ADL)	Baseline, 13 weeks, and 26 weeks	score on a scale	MEAN
SECONDARY	Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog14)	Baseline, 13 weeks, and 26 weeks	score on a scale	MEAN
SECONDARY	Safety and Tolerability - Blood Pressure (mmHg)	Baseline, and 26 weeks	mmHg	MEAN
SECONDARY	Safety and Tolerability - Heart Rate (Bpm)	Baseline, and 26 weeks	bpm	MEAN
SECONDARY	Safety and Tolerability - ECG Interval Results - QTcF (Msec)	Baseline, and 26 weeks	msec	MEAN
SECONDARY	Safety and Tolerability - Hematology	Baseline, and 26 weeks	GI/L	MEAN
SECONDARY	Safety and Tolerability - Blood Chemistry (mmol/L)	Baseline, and 26 weeks	mmol/L	MEAN
OTHER_PRE_SPECIFIED	NeuroPsychiatric Inventory (NPI) Total Score	Baseline, and 26 weeks	NPI total score	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group180

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline	Piromelatine 5 mg		0.0434	95% Confidence Interval -0.0728 to 0.1391	z-score
Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline	Piromelatine 20 mg		0.1175	95% Confidence Interval 0.0121 to 0.2153	z-score
Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline	Piromelatine 50 mg		0.0297	95% Confidence Interval -0.0900 to 0.1247	z-score
Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline	Placebo Comparator		0.0591	95% Confidence Interval -0.0435 to 0.1483	z-score
Change From Baseline in Global Impression of Change (CGIC)	Experimental: Piromelatine 5 mg	13 weeks	3.93	Standard Deviation 0.88	score on a scale
Change From Baseline in Global Impression of Change (CGIC)	Experimental: Piromelatine 20 mg	13 weeks	3.95	Standard Deviation 0.78	score on a scale
Change From Baseline in Global Impression of Change (CGIC)	Experimental: Piromelatine 50 mg	13 weeks	3.87	Standard Deviation 0.92	score on a scale
Change From Baseline in Global Impression of Change (CGIC)	Placebo Comparator: Placebo	13 weeks	3.89	Standard Deviation 0.80	score on a scale
Change From Baseline in Global Impression of Change (CGIC)	Experimental: Piromelatine 5 mg	26 weeks	4.13	Standard Deviation 1.07	score on a scale
Change From Baseline in Global Impression of Change (CGIC)	Experimental: Piromelatine 20 mg	26 weeks	3.94	Standard Deviation 1.02	score on a scale

1 to 10 of 180Source ClinicalTrials.gov

See all 180 results by group

Participant flow28

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run-In Phase (2 Weeks)	STARTED	Experimental: Piromelatine 5 mg	89
Run-In Phase (2 Weeks)	STARTED	Experimental: Piromelatine 20 mg	88
Run-In Phase (2 Weeks)	STARTED	Experimental: Piromelatine 50 mg	88
Run-In Phase (2 Weeks)	STARTED	Placebo Comparator	106
Run-In Phase (2 Weeks)	COMPLETED	Experimental: Piromelatine 5 mg	89
Run-In Phase (2 Weeks)	COMPLETED	Experimental: Piromelatine 20 mg	88
Run-In Phase (2 Weeks)	COMPLETED	Experimental: Piromelatine 50 mg	88
Run-In Phase (2 Weeks)	COMPLETED	Placebo Comparator	106
Run-In Phase (2 Weeks)	NOT COMPLETED	Experimental: Piromelatine 5 mg	0
Run-In Phase (2 Weeks)	NOT COMPLETED	Experimental: Piromelatine 20 mg	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 participant flow

Adverse events325

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Piromelatine 5 mg	0	88	0
other	Headache	Nervous system disorders	Piromelatine 20 mg	3	88	6
other	Headache	Nervous system disorders	Piromelatine 50 mg	1	87	1
other	Headache	Nervous system disorders	Placebo Comparator	8	105	15
other	Headache	Nervous system disorders	Run-In Phase	0	368	0
other	Abnormal dreams	Psychiatric disorders	Piromelatine 5 mg	1	88	1
other	Abnormal dreams	Psychiatric disorders	Piromelatine 20 mg	1	88	1
other	Abnormal dreams	Psychiatric disorders	Piromelatine 50 mg	3	87	3
other	Abnormal dreams	Psychiatric disorders	Placebo Comparator	2	105	2
other	Abnormal dreams	Psychiatric disorders	Run-In Phase	0	368	0

1 to 10 of 325Source ClinicalTrials.gov

See all 325 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Piromelatine 5 mg	1	88
Total, all-cause mortality	Piromelatine 20 mg	0	88
Total, all-cause mortality	Piromelatine 50 mg	0	87
Total, all-cause mortality	Placebo Comparator	0	105
Total, all-cause mortality	Run-In Phase	0	368
Total, other adverse events	Piromelatine 5 mg	12	88
Total, other adverse events	Piromelatine 20 mg	14	88
Total, other adverse events	Piromelatine 50 mg	14	87
Total, other adverse events	Placebo Comparator	29	105
Total, other adverse events	Run-In Phase	0	368

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35542997	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
1-Back Task	Primary outcome	ConductCognition
Verbal Fluency	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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