A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease (ACT-AD)

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ClinicalTrials.gov Identifier: NCT04491006

Recruitment Status : Completed

First Posted : July 29, 2020

Results First Posted : June 12, 2023

Last Update Posted : June 12, 2023

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Sponsor:

Collaborator:

National Institute on Aging (NIA)

Information provided by (Responsible Party):

Athira Pharma

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Alzheimer Disease Dementia of Alzheimer Type
Interventions	Drug: ATH-1017 Drug: Placebo
Enrollment	77

Participant Flow

Recruitment Details	The study was conducted at a total of 6 centers in Australia and 8 centers in the United States (US).
Pre-assignment Details	This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study comparing ATH-1017 40 milligrams per day (mg/day) and ATH-1017 70 mg/day with placebo in participants with a clinical diagnosis of mild to moderate Alzheimer's disease (AD).


Arm/Group Title	Placebo	ATH-1017 40 Milligrams (mg)	ATH-1017 70 mg
Arm/Group Description	Participants were randomized to rec...	Participants were randomized to rec...	Participants were randomized to rec...
Arm/Group Description	Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
Period Title: Overall Study
Started	24	27	26
Completed	23	24	19
Not Completed	1	3	7
Reason Not Completed
Adverse Event	0	3	5
Withdrawal by Subject	1	0	2

Baseline Characteristics

Arm/Group Title		Placebo	ATH-1017 40 mg	ATH-1017 70 mg	Total
Arm/Group Description		Participants were randomized to rec...	Participants were randomized to rec...	Participants were randomized to rec...	Total of all reporting groups
Arm/Group Description		Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Total of all reporting groups
Overall Number of Baseline Participants		24	27	26	77
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Safety Population: included all randomized participants who received at least one dose of the study medication.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	24 participants	27 participants	26 participants	77 participants
		70.0 (8.03)	70.6 (6.54)	73.4 (7.26)	71.4 (7.32)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	24 participants	27 participants	26 participants	77 participants
	Female	12 50.0%	15 55.6%	12 46.2%	39 50.6%
	Male	12 50.0%	12 44.4%	14 53.8%	38 49.4%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	24 participants	27 participants	26 participants	77 participants
	Hispanic or Latino	3 12.5%	0 0.0%	0 0.0%	3 3.9%
	Not Hispanic or Latino	21 87.5%	27 100.0%	26 100.0%	74 96.1%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	24 participants	27 participants	26 participants	77 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	1 4.2%	0 0.0%	1 3.8%	2 2.6%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 4.2%	2 7.4%	1 3.8%	4 5.2%
	White	22 91.7%	25 92.6%	24 92.3%	71 92.2%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Event-related Potential (ERP) P300 Latency at Baseline
Description	ERP P300 was a method of recording brain activity elicited by external...
Description	ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit. Baseline was defined as Day 1.
Time Frame	At Baseline (Day 1)

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT) Population: included all randomized participants who took at least one dose of the study medication and who completed at least one ERP P300 Baseline assessment and/or one post-Baseline ERP P300 assessment.


Arm/Group Title	Placebo	ATH-1017 40 mg	ATH-1017 70 mg
Arm/Group Description:	Participants were randomized to rec...	Participants were randomized to rec...	Participants were randomized to rec...
Arm/Group Description:	Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
Overall Number of Participants Analyzed	23	26	25
Mean (Standard Deviation) Unit of Measure: Milliseconds (ms)
	361.5 (32.23)	382.3 (40.18)	375.3 (35.77)

2.Secondary Outcome


Title	Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline
Description	The ADAS-Cog11 was designed to measure cognitive symptom change in par...
Description	The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. It was performed to evaluate the correlation of ERP P300 latency and cognition. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1.
Time Frame	At Baseline (Day 1)

Outcome Measure Data

Analysis Population Description

mITT Population. Only those participants with data available at the specified data points were analyzed.


Arm/Group Title	Placebo	ATH-1017 40 mg	ATH-1017 70 mg
Arm/Group Description:	Participants were randomized to rec...	Participants were randomized to rec...	Participants were randomized to rec...
Arm/Group Description:	Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
Overall Number of Participants Analyzed	23	25	25
Mean (Standard Deviation) Unit of Measure: Scores on a scale
	23.0 (7.96)	22.4 (8.94)	20.7 (7.18)

Adverse Events

Time Frame	Up to Week 30
Adverse Event Reporting Description	Safety population which included all randomized participants who received at least one dose of the study medication.

Arm/Group Title	Placebo	ATH-1017 40 mg	ATH-1017 70 mg
Arm/Group Description	Participants were randomized to rec...	Participants were randomized to rec...	Participants were randomized to rec...
Arm/Group Description	Participants were randomized to receive placebo via subcutaneous (SC) injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30	Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
All-Cause Mortality
	Placebo	ATH-1017 40 mg	ATH-1017 70 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/24 (0.00%)	0/27 (0.00%)	0/26 (0.00%)
Serious Adverse Events Serious Adverse Events
	Placebo	ATH-1017 40 mg	ATH-1017 70 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/24 (0.00%)	3/27 (11.11%)	0/26 (0.00%)
Ear and labyrinth disorders
Vertigo ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Injury, poisoning and procedural complications
Hip fracture ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Nervous system disorders
Cholinergic syndrome ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
1 Term from vocabulary, MedDRA 23.1 * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Placebo	ATH-1017 40 mg	ATH-1017 70 mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	18/24 (75.00%)	24/27 (88.89%)	26/26 (100.00%)
Blood and lymphatic system disorders
Eosinophilia ^* 1	1/24 (4.17%)	6/27 (22.22%)	5/26 (19.23%)
Anaemia ^* 1	0/24 (0.00%)	1/27 (3.70%)	2/26 (7.69%)
Neutrophilia ^* 1	0/24 (0.00%)	2/27 (7.41%)	0/26 (0.00%)
Neutropenia ^* 1	2/24 (8.33%)	0/27 (0.00%)	0/26 (0.00%)
Thrombocytopenia ^* 1	1/24 (4.17%)	1/27 (3.70%)	0/26 (0.00%)
Cardiac disorders
Bradycardia ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Atrial fibrillation ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Ear and labyrinth disorders
Tinnitus ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Vertigo ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Eye disorders
Blepharitis ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Amaurosis fugax ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Gastrointestinal disorders
Nausea ^* 1	2/24 (8.33%)	1/27 (3.70%)	1/26 (3.85%)
Vomiting ^* 1	0/24 (0.00%)	1/27 (3.70%)	1/26 (3.85%)
Diarrhoea ^* 1	0/24 (0.00%)	1/27 (3.70%)	3/26 (11.54%)
Constipation ^* 1	2/24 (8.33%)	0/27 (0.00%)	0/26 (0.00%)
Colitis ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Toothache ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Hiatus hernia ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Abdominal pain upper ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Enteritis ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
General disorders
Injection site reaction ^* 1	1/24 (4.17%)	17/27 (62.96%)	21/26 (80.77%)
Injection site vesicles ^* 1	0/24 (0.00%)	4/27 (14.81%)	1/26 (3.85%)
Injection site pain ^* 1	0/24 (0.00%)	3/27 (11.11%)	1/26 (3.85%)
Injection site induration ^* 1	1/24 (4.17%)	1/27 (3.70%)	1/26 (3.85%)
Injection site nodule ^* 1	0/24 (0.00%)	0/27 (0.00%)	3/26 (11.54%)
Injection site bruising ^* 1	1/24 (4.17%)	0/27 (0.00%)	1/26 (3.85%)
Injection site erythema ^* 1	0/24 (0.00%)	2/27 (7.41%)	0/26 (0.00%)
Injection site paraesthesia ^* 1	0/24 (0.00%)	1/27 (3.70%)	1/26 (3.85%)
Injection site pruritus ^* 1	0/24 (0.00%)	1/27 (3.70%)	1/26 (3.85%)
Injection site mass ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Injection site oedema ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Injection site rash ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Fatigue ^* 1	0/24 (0.00%)	4/27 (14.81%)	1/26 (3.85%)
Chest discomfort ^* 1	0/24 (0.00%)	1/27 (3.70%)	1/26 (3.85%)
Chest pain ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Pain ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Flushing ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Hot flush ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Induration ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Adverse drug reaction ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Immediate post-injection reaction ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Application site pruritus ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Feeling abnormal ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Infections and infestations
Nasopharyngitis ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Upper respiratory tract infection ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Ear infection ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Respiratory tract infection ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Urinary tract infection ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Injury, poisoning and procedural complications
Fall ^* 1	0/24 (0.00%)	2/27 (7.41%)	2/26 (7.69%)
Wound secretion ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Contusion ^* 1	0/24 (0.00%)	2/27 (7.41%)	2/26 (7.69%)
Skin abrasion ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Post procedural complication ^* 1	0/24 (0.00%)	2/27 (7.41%)	0/26 (0.00%)
Joint injury ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Hip fracture ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Muscle strain ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Rib fracture ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Vaccination complication ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Investigations
Blood glucose increased ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Electrocardiogram QT prolonged ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Liver function test abnormal ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Intraocular pressure increased ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Blood creatinine increased ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Blood alkaline phosphatase increased ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Eosinophil count increased ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
White blood cell count increased ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Metabolism and nutrition disorders
Hyperlipidaemia ^* 1	0/24 (0.00%)	1/27 (3.70%)	1/26 (3.85%)
Hypoglycaemia ^* 1	1/24 (4.17%)	1/27 (3.70%)	0/26 (0.00%)
Decreased appetite ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	0/24 (0.00%)	1/27 (3.70%)	2/26 (7.69%)
Pain in extremity ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Arthralgia ^* 1	0/24 (0.00%)	3/27 (11.11%)	0/26 (0.00%)
Bursitis ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Polymyalgia rheumatica ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Muscle spasms ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Tendonitis ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Nervous system disorders
Headache ^* 1	1/24 (4.17%)	4/27 (14.81%)	2/26 (7.69%)
Dizziness ^* 1	2/24 (8.33%)	2/27 (7.41%)	3/26 (11.54%)
Dizziness postural ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Paraesthesia ^* 1	0/24 (0.00%)	3/27 (11.11%)	1/26 (3.85%)
Extensor plantar response ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Hyporeflexia ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Dysgeusia ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Sensory disturbance ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Dementia Alzheimer's type ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Cholinergic syndrome ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Dysdiadochokinesis ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Syncope ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Facial paralysis ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Hypersomnia ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Parosmia ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Dysarthria ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Tremor ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Psychiatric disorders
Agitation ^* 1	1/24 (4.17%)	1/27 (3.70%)	1/26 (3.85%)
Anxiety ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Confusional state ^* 1	1/24 (4.17%)	0/27 (0.00%)	1/26 (3.85%)
Disorientation ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Hallucination ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Hallucination, visual ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Delirium ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Depressive symptom ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Dysphemia ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Renal and urinary disorders
Pollakiuria ^* 1	0/24 (0.00%)	2/27 (7.41%)	0/26 (0.00%)
Reproductive system and breast disorders
Genital paraesthesia ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Vulvovaginal burning sensation ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Lung disorder ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Skin and subcutaneous tissue disorders
Pruritus ^* 1	1/24 (4.17%)	4/27 (14.81%)	1/26 (3.85%)
Pruritus allergic ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Lipohypertrophy ^* 1	0/24 (0.00%)	2/27 (7.41%)	0/26 (0.00%)
Rash ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Rash pruritic ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Night sweats ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Skin induration ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Dermatitis ^* 1	0/24 (0.00%)	0/27 (0.00%)	1/26 (3.85%)
Skin exfoliation ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Hair colour changes ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Urticaria ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Vascular disorders
Hypotension ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
Orthostatic hypotension ^* 1	1/24 (4.17%)	0/27 (0.00%)	0/26 (0.00%)
Flushing ^* 1	0/24 (0.00%)	1/27 (3.70%)	0/26 (0.00%)
1 Term from vocabulary, MedDRA 23.1 * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Hans Moebius, CMO
Organization:	Athira Pharma
Phone:	1-866-725-0930
EMail:	clinicaltrials@athira.com

Publications:

McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

Layout table for additonal information

Responsible Party:	Athira Pharma
ClinicalTrials.gov Identifier:	NCT04491006
Other Study ID Numbers:	ATH-1017-AD-0202 U1111-1255-9714 ( Other Identifier: WHO (UTN) ) 18PTC-R-589358 ( Other Grant/Funding Number: Alzheimer's Association ) 1R01AG068268-01 ( U.S. NIH Grant/Contract )
First Submitted:	July 23, 2020
First Posted:	July 29, 2020
Results First Submitted:	May 20, 2023
Results First Posted:	June 12, 2023
Last Update Posted:	June 12, 2023

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