TerminatedPhase 2Results posted

Efficacy and Safety of MK-7622 as Adjunct Therapy in Participants With Alzheimer's Disease (MK-7622-012)

A Seamless Phase IIa/IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of MK-7622 as an Adjunctive Therapy for Symptomatic Treatment in Subjects With Alzheimer's Disease

Lead sponsor

Merck Sharp & Dohme LLC

Asset

MK-7622

Listed sites

Recruiting sites

Enrollment

240

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•ADAS-Cog•Adverse Event (AE)•Number of Participants Who Discontinued Study Drug Due to an AE

Identifiers

Registered as

Eudract number2013-000937-11

Org study ID7622-012

Secondary IDMK-7622-012Merck Protocol Number

NCT IDNCT01852110

Timeline

Milestones

Study first posted2013-05-13estimated

Study start2013-10-22actual

Primary completion2016-04-11actual

Study completion2016-04-11actual

Results first posted2018-02-07actual

Last update posted2018-09-18actual

Assets

Drug assets

MK-7622

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD based on both

a)the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria and

b)the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for AD

•AD is of mild to moderate severity

•Clear history of cognitive and functional decline over at least one year that is either

a)documented in medical records or

b)documented by history from an informant who knows the participant well

•On a stable and effective daily dose of AChEI (either donepezil, rivastigmine, or galantamine), for at least two months before Screening, and willing to remain on the same dose for the duration of the trial. Effective doses are considered to be: donepezil, 10 mg total daily dose administered orally; rivastigmine, 9.5 or 13.3 mg/24 hours administered by transdermal patch or 6-12 mg total daily dose administered orally; galantamine, 16-24 mg total daily dose administered orally

•Able to read at a 6th grade level or equivalent, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation

•Have a reliable and competent trial partner who must have a close relationship with the subject

Exclusion criteria

•History of clinically significant stroke

•Evidence of a neurological disorder other than the disease being studied (i.e., probable AD)

•History of seizures or epilepsy within the last 5 years before Screening

•Evidence of a clinically relevant or unstable psychiatric disorder, excluding major depression in remission

•Is at imminent risk of self-harm or of harm to others

•History of alcoholism or drug dependency/abuse within the last 5 years before Screening

•Does not have a magnetic resonance imaging (MRI) scan obtained within 12 months of Screening and is unwilling or not eligible to undergo an MRI scan at Screening

•History of hepatitis or liver disease that has been active within the six months prior to Screening Visit

•Recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of the Screening Visit (e.g., diabetes, hypertension, thyroid or endocrine disease, congestive heart failure, angina, cardiac or gastrointestinal disease, dialysis, or abnormal renal function) other than the condition being studied such that participation in the trial would pose a significant medical risk to the participant. Controlled co-morbid conditions are not exclusionary if stable within three months of the Screening Visit

•History or current evidence of long QT syndrome, corrected QT (QTc) interval ≥470 milliseconds (for male subjects) or ≥480 milliseconds (for female subjects), or torsades de pointes

•History of malignancy occurring within the five years before Screening, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or localized prostate carcinoma which has been treated with potentially curative therapy with no evidence of recurrence for ≥3 year post-therapy

•Clinically significant vitamin B12 deficiency, or increased thyroid stimulating hormone (TSH) in the six months before Screening

•Major surgery within 3 months of Screening

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Global cognition

Function / daily living

Safety / tolerability / PK

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Composite Cognition Score-3 Domain (CCS-3D) at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)

Time frame:Baseline and week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline in Composite Cognition Score-3 Domain (CCS-3D) at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)

Time frame:Baseline and week 12

change from baseline, improvement

Posted result

Group	Value (mean), z-score	Standard error
MK-7622 High Dose - 45 mg (Stage 1)n=108 Participants	0.13	0.043
Placebo (Stage 1)n=110 Participants	0.03	0.042

Mean Difference (Final Values)0.1095% CI-0.01 - 0.22p0.0829Constrained Longitudinal Data Analysis

Memory

6 endpoints

Primary/protocol endpoint

Change From Baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)

Time frame:Baseline and week 12

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in ADAS-Cog11 Score at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)

Time frame:Baseline and week 12

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)

Time frame:Baseline and week 12

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), Score on a Scale	Standard error
MK-7622 High Dose - 45 mg (Stage 1)n=119 Participants	0.39	0.440
Placebo (Stage 1)n=120 Participants	0.21	0.416

Mean Difference (Final Values)0.1895% CI-1.00 - 1.37p0.7623Constrained Longitudinal Data Analysis

Primary/registry result

Change From Baseline in ADAS-Cog11 Score at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)

Time frame:Baseline and week 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CCS-3D at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)

Time frame:Baseline and Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline in CCS-3D at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)

Time frame:Baseline and Week 12

change from baseline, improvement

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) at Week 24 (Combining Stage 1 and 2, MK-7622 45 mg Versus Placebo)

Time frame:Baseline and week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) at Week 24 (Combining Stage 1 and 2, MK-7622 45 mg Versus Placebo)

Time frame:Baseline and week 24

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), Score on a Scale	Standard error
MK-7622 High Dose - 45 mg (Stage 1)n=119 Participants	-2.66	0.919
Placebo (Stage 1)n=119 Participants	-2.73	0.853

Mean Difference (Final Values)0.0695% CI-2.42 - 2.54p0.9604Constrained Longitudinal Data Analysis

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants Experiencing an Adverse Event (AE)

Time frame:Up to 26 weeks

event count, event

Primary/registry result

Number of Participants Experiencing an Adverse Event (AE)

Time frame:Up to 26 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
MK-7622 High Dose - 45 mg (Stage 1)n=119 Participants	83	-
Placebo (Stage 1)n=120 Participants	71	-

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Number of Participants Who Discontinued Study Drug Due to an AE

Time frame:Up to 24 weeks

event count, event

Primary/registry result/low confidence

Number of Participants Who Discontinued Study Drug Due to an AE

Time frame:Up to 24 weeks

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
MK-7622 High Dose - 45 mg (Stage 1)n=119 Participants	19	-
Placebo (Stage 1)n=120 Participants	7	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Voss T, Li J, Cummings J, Farlow M, Assaid C, Froman S, Leibensperger H, Snow-Adami L, McMahon KB, Egan M, Michelson D. Randomized, controlled, proof-of-concept trial of MK-7622 in Alzheimer's disease. Alzheimers Dement (N Y). 2018 Apr 26;4:173-181. doi: 10.1016/j.trci.2018.03.004. eCollection 2018.
PMID29955661via RESULT

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.